FDA UDI
In Commercial Distribution
🇺🇸 United States
DEKNATEL
DI: 14026704638656
·
Model: IPN029125
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DEKNATEL
- Primary DI
- 14026704638656
- Version / Model
- IPN029125
- Catalog Number
- EX-6681
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-03
- Public Version
- 7
- Public Version Date
- 2023-08-31
- Public Version Status
- Update
- Public Device Record Key
- e2d245c4-b401-4dd3-8695-0ef50d1cc719
Device Description
PLEDGET SOFT 5/8 INCHES X 3/8 INCHES X 1/16 INCHES X 6
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
- MR Safe
- 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 | 34026704638650 | GS1 | Box | 36 | In Commercial Distribution | |
| Primary | 14026704638656 | GS1 | ||||
| Previous | 04026704416257 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153089 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Soft Pledget /Needle 5/8" x 3/8" x 1/16" | ||
| Length | 75 | Centimeter |