AccessGUDID - DEVICE: TYRX™ Absorbable Antibacterial Envelope

GUDID

Device Identifier (DI) Information

Brand Name: TYRX™ Absorbable Antibacterial Envelope - Large
Version or Model: CMRM6133
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169468795
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: ENVELOPE CMRM6133 ABSORB LRG US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61126	Implantable pulse generator mesh bag, bioabsorbable	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, surgical, polymeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130943	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Envelope size 2.9" x 3.3" (7.4cm x 8.5cm)

Device Record Status

Public Device Record Key: ebe9e38e-9c4c-49c4-bddc-f5b0b7dfea34
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: June 10, 2015