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TYRX™ Absorbable Antibacterial Envelope - Large

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
TYRX™ Absorbable Antibacterial Envelope - Large FDA UDI
Generic Name
Implantable pulse generator mesh bag, bioabsorbable FDA UDI
Device Name
ENVELOPE CMRM6133 ABSORB LRG US FDA UDI
Model / Reference
CMRM6133 FDA UDI
Description
ENVELOPE CMRM6133 ABSORB LRG US FDA UDI

Identifiers

Primary DI / UDI-DI
00643169468795 FDA UDI
510(k) Number
K130943 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Implantable pulse generator mesh bag, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Implantable pulse generator mesh bag, bioabsorbable

TYRX™ Absorbable Antibacterial Envelope - Large by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable pulse generator mesh bag, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI ebe9e38e-9c4c-49c4-bddc-f5b0b7dfea34 37 fields · synced May 30, 2026