FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Premipatch
DI: 04046963316853
·
Model: C0027992
·
B BRAUN SURGICAL SA
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
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Basic Information
- Brand Name
- Premipatch
- Primary DI
- 04046963316853
- Version / Model
- C0027992
- Catalog Number
- C0027992
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2015-08-06
- Public Version
- 5
- Public Version Date
- 2026-03-31
- Public Version Status
- Update
- Public Device Record Key
- b1e9dd47-ddbc-426c-8a6d-e88869c06f0c
- Distribution End Date
- 2025-11-30
Device Description
PREMIPATCH 6 PTFE SOFT PLEDGETS 9X5MM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | General, Plastic Surgery | 878.5000 | 2 |
| DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | Cardiovascular | 870.3470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963316853 | GS1 | ||||
| Unit of Use | 04046963316846 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Pledget : 9x5 | ||
| Device Size Text, specify | Thread Material : PTFE |