ENVELOPE NMRM6122 ABSORB MED MR
TYRX™ - NMRM6122
Device Description
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.
Environmental Conditions
- 25.00
- 2.00
- 77.00
- 36.00
Device Sizes
- Length: 2.7 Inch
- Width: 6.3 Centimeter
- Length: 6.9 Centimeter
- Width: 2.5 Inch
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: 00763000307899
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
