Identity
- Trade Name
- DemeSTEEL FDA UDI
- Generic Name
- Metallic suture, multifilament FDA UDI
- Device Name
- Stainless Steel Surgical Non Absorbable Suture FDA UDI
- Model / Reference
- SW5x110390B4P FDA UDI
- Description
- Stainless Steel Surgical Non Absorbable Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10652927783183 FDA UDI
- 510(k) Number
- K141007 FDA UDI
- FDA Product Code
- GAQ FDA UDI
- GMDN Term
- Metallic suture, multifilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4495 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metallic suture, multifilament
DemeSTEEL by DemeTECH Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic suture, multifilament.
- ETHICON — Ethicon Inc. · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- ETHICON — Ethicon Inc. · Class II
- PONTiS Suture-Crimp Implant — Pontis Orthopaedics, LLC · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
Cleared under the same submission
K141007 also covers:
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
- DemeSTEEL — DemeTECH Corp
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 II | Pending data |
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Manufacturer
- Manufacturer
- DemeTECH Corp
Sources (1)
- FDA UDI d2b7bcd0-55c5-4cba-ab2b-345f6dfa9622 34 fields · synced May 30, 2026