FDA UDI
In Commercial Distribution
🇺🇸 United States
DEKNATEL
DI: 04026704423613
·
Model: IPN012603
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DEKNATEL
- Primary DI
- 04026704423613
- Version / Model
- IPN012603
- Catalog Number
- G7-100C9K
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0b0ad637-bf93-4f53-82e6-83424145077e
Device Description
TEV TRI BR 2-0 C-2 30"X9 PFM
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
- Yes
- 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 |
|---|---|---|---|---|
| GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13906 | Polyester suture, non-bioabsorbable, multifilament | A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704423617 | GS1 | Sleeve | 1 | In Commercial Distribution | |
| Primary | 04026704423613 | GS1 | ||||
| Package | 44026704423611 | GS1 | Box | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001440 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Centimeter | |
| Device Size Text, specify | TEVDEK® II /Needle C-2 Size-2-0 |