ENVELOPE CMRM3133 ANTIBAC LRG US

ENVELOPE CMRM3133 ANTIBAC LRG US
TYRX™ Antibacterial Envelope - Large - CMRM3133

An implantable woven/knitted or porous bag made from a bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted. The device includes an antimicrobial coating intended to reduce the risk of infection.

• Envelope size 2.9" x 3.3" (7.4cm x 8.5cm)

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FTL

Device Name: Mesh, Surgical, Polymeric

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.3300

Third Party Flag: N

Medical Specialty: SU

Device Id: 00643169468818

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A