AccessGUDID - DEVICE: Premipatch (04038653925124)

GUDID

Device Identifier (DI) Information

Brand Name: Premipatch
Version or Model: C0027996
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C0027996
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04038653925124
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2025
Device Count: 36
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: PREMIPATCH 6 PTFE FIRM PLEDGETS 3X3MM

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:	No
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?
31744	Cardiovascular patch, synthetic	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAW	SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Pledget : 3x3
Device Size Text, specify: Thread Material : PTFE

Device Record Status

Public Device Record Key: 815db153-f152-40ba-a486-b7b728cc4464
Public Version Date: March 18, 2025
Public Version Number: 9
DI Record Publish Date: August 06, 2015