Greatbatch Medical

Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.

Cardiovascular Devices

2

No

Worldwide Distribution: United States, including the states of MN and CA.

Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.

Cardiovascular Devices

3

Yes

Worldwide Distribution: to USA and Europe, through distributor in MN.

enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

Serial numbers: 148236, 148237, 148238, 148239, 148240, 148241, 148242, 148243, 148036, 148038, 148039, 148040, 148041, 148042, 148043, 148044, 148045, 148046, 148047, 148048, 148049, 148050, 148051, 148052, 148053, 148054, 148055, 148056, 148057, 148058, 148059, 148060, 148061, 148063, 148064, 148065, 148066, 148067, 148068, 148069, 148070, 148071, 148072, 148074, 148075.

Cardiovascular Devices

3

Yes

CA and MN

Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423,  148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438.

Cardiovascular Devices

3

Yes

CA and MN

Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.