FDA UDI
In Commercial Distribution
🇺🇸 United States
DEKNATEL
DI: 14026704724151
·
Model: IPN055509
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Basic Information
- Brand Name
- DEKNATEL
- Primary DI
- 14026704724151
- Version / Model
- IPN055509
- Catalog Number
- V-3278
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-06-11
- Public Version
- 1
- Public Version Date
- 2021-06-21
- Public Version Status
- New
- Public Device Record Key
- 3c450eae-3692-498f-bcf6-21a8506e0ccc
Device Description
V-PAK (XG6-420GWM8)X2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| OVN | Suture kit | General, Plastic Surgery | 878.4830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56303 | Suture kit, non-medicated | A collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704724158 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 14026704724151 | GS1 | ||||
| Unit of Use | 34026704724155 | GS1 | ||||
| Previous | 14026704425225 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Inch | |
| Device Size Text, specify | Green Braided 'silky' II POLYDEK® (Firm Pledget 1/4" x 1/8" x 1/16") C-2, C-2Needle/ Size- 2-0 |