Devices

Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-946, 46 lots: 109010131 109020438 109030630 109030725 109061221 109061458 109081891 109102354 109112606 109122828 110010121 110020416 110030690 110041052 110071718 110092291 110092375 110112686 110122949 111010174 111020307 111040981 111051220 111061571 111071946 111082118 111092409 111102788 112010212 112020507 112030756 112041364 112052026 112072879 112083443 112093956 112114687 112125122 113025973 113036807 113057516 113089090 113109650 113109883 140111260 140111318
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • 제품 설명
    STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF || (2) GOWN STANDARD LARGE SMS || (3) TOWELS ABSORBENT 15" X 20" UF || (1) MAYO STAND COVER REINFORCED UF || (1) DRAPE SHEET 41" X 58" SMS || (4) DRAPE UTILITY WITH TAPE L/F || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

제조사

Customed, Inc
  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
    Customed Inc
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 331 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9001296 || PREMIUM LAPAROTOMY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900169 || UNIVERSAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOT: SL15209 (150719960) 31-JUL-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9001738 || UROLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900010 SUTURE REMOVAL KIT || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
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