ENVELOPE NMRM6133 ABSORB LRG MR

ENVELOPE NMRM6133 ABSORB LRG MR
TYRX™ - NMRM6133

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

Storage Environment Temperature - Degrees Fahrenheit

77.00
36.00

Storage Environment Temperature - Degrees Celsius

25.00
2.00

Device Sizes

Width: 2.9 Inch

Width: 7.4 Centimeter

Length: 3.3 Inch

Length: 8.5 Centimeter

Width: 2.9 Inch
Width: 7.4 Centimeter
Length: 3.3 Inch
Length: 8.5 Centimeter

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: 00763000307905

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