Cooper Surgical, Inc.

Lot 113367

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 || Intended for use in contraception.

Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13

Radiology Devices

2

No

Nationwide Distribution including Puerto Rico

LEEP REDIKIT Product No. 6060 || In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

Lot Number:117301

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex || Part Number: MXPCON04 || A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Lot Number:117443

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex || :Part Number: MXPCONDS05 || A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Lot Number:111732

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex || Part Number: MXKPCONDS00 || A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.