Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Metallic suture, multifilament FDA UDI
- Device Name
- Ethi-Pack Pre-Cut Steel Suture FDA UDI
- Model / Reference
- 17648/25 FDA UDI
- Description
- Ethi-Pack Pre-Cut Steel Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094176482 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Metallic suture, multifilament 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metallic suture, multifilament
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic suture, multifilament.
- ETHICON — Ethicon Inc. · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- ETHICON — Ethicon Inc. · Class II
- DemeSTEEL — DemeTECH Corp · Class II
- PONTiS Suture-Crimp Implant — Pontis Orthopaedics, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI 4f3c1d42-f3cb-4e27-9091-f138858c408c 33 fields · synced May 31, 2026