Micro Introducer Kits

Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).

Cardiovascular Devices

2

No

USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN

AngioDynamics Micro Introducer Kits under the following labeling: || 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. || Product Usage: || This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

Batch/Lot: 1) 5046426, 2) 5022317, 5032458, 5040672, 5046428, 5063983 & 5081983

Cardiovascular Devices

2

No

Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 || Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

Batch/Lot: 1) 5034280, 5067423, 2) 5061461, 5070972

Cardiovascular Devices

2

No

Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX

ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070 || Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick