DEVICE: Premipatch (04046963316815)
Device Identifier (DI) Information
Premipatch
C0027990
In Commercial Distribution
C0027990
B BRAUN SURGICAL SA
C0027990
In Commercial Distribution
C0027990
B BRAUN SURGICAL SA
PREMIPATCH 6 PTFE SOFT PLEDGETS 3X3MM
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| 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 | |
Sterilization
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
20b67fb8-9de4-48a5-9e1e-4e70d615fca6
May 07, 2021
6
August 06, 2015
May 07, 2021
6
August 06, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
04046963316808
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com