FDA UDI
In Commercial Distribution
🇺🇸 United States
PTFE Polymer Pledgets
DI: 10884521104631
·
Model: 88868679-01
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PTFE Polymer Pledgets
- Primary DI
- 10884521104631
- Version / Model
- 88868679-01
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-31
- Public Version
- 7
- Public Version Date
- 2023-03-14
- Public Version Status
- Update
- Public Device Record Key
- fd092e04-7c1e-4c3d-a26b-c4a32f1dd3a3
Device Description
Nonabsorbable Pre-punched Pledgets,5x Soft PTFE Pledgets 9.5x4.8x1.5mm
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20884521104638 | GS1 | CASE | 36 | In Commercial Distribution | |
| Primary | 10884521104631 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953289 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 130 Degrees Fahrenheit