FDA UDI
In Commercial Distribution
🇺🇸 United States
DEKNATEL
DI: 04026704626694
·
Model: IPN912379
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- DEKNATEL
- Primary DI
- 04026704626694
- Version / Model
- IPN912379
- Catalog Number
- GFS-10A
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2018-03-26
- Public Version
- 1
- Public Version Date
- 2018-04-26
- Public Version Status
- New
- Public Device Record Key
- 91f0faef-47ff-40ab-8f91-e7cc1f641084
Device Description
GABBAY-FRATER SUTORGANIZER (4 PIECES OF 3)
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36129 | Suturing guide | A surgical device that is placed over an open wound to the aid the surgeon in placing the sutures so that, when pulled tight, the sutures will meet. It is typically made of metal or plastic material. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14026704626691 | GS1 | Sleeve | 4 | In Commercial Distribution | |
| Primary | 04026704626694 | GS1 | ||||
| Unit of Use | 44026704626692 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 90 | Centimeter |