Identity
- Trade Name
- DEKNATEL FDA UDI
- Generic Name
- Suturing guide FDA UDI
- Device Name
- GABBAY-FRATER SUTORGANIZER (4 PIECES OF 3) FDA UDI
- Model / Reference
- IPN912379 FDA UDI
- Description
- GABBAY-FRATER SUTORGANIZER (4 PIECES OF 3) FDA UDI
Identifiers
- Catalog Number
- GFS-10A FDA UDI
- Primary DI / UDI-DI
- 04026704626694 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Suturing guide FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDI
Category: Suturing guide
Deknatel by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 91f0faef-47ff-40ab-8f91-e7cc1f641084 36 fields · synced May 30, 2026