← Back to catalogue

Tyrx™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
TYRX™ FDA UDI
Generic Name
Implantable pulse generator mesh bag, bioabsorbable FDA UDI
Device Name
ENVELOPE CMRM6122 ABSORB MED MR FDA UDI
Model / Reference
CMRM6122 FDA UDI
Description
ENVELOPE CMRM6122 ABSORB MED MR FDA UDI

Identifiers

Primary DI / UDI-DI
00763000307875 FDA UDI
510(k) Number
K180030 FDA UDI
K192389 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
MRI Safety
MR Safe FDA UDI

Category: Implantable pulse generator mesh bag, bioabsorbable

Tyrx™ 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.

Cleared under the same submission

K180030 also covers:

K192389 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 534c2090-37a3-4da7-b421-ec2ee369ff8e 37 fields · synced May 30, 2026