Identity
- Trade Name
- Black Belt Blunt Ti Blade FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Black Belt Blunt Titanium Blade 22 x 40mm FDA UDI
- Model / Reference
- 7324-40T FDA UDI
- Description
- Black Belt Blunt Titanium Blade 22 x 40mm FDA UDI
Identifiers
- Catalog Number
- 7324-40T FDA UDI
- Primary DI / UDI-DI
- 10840199503145 FDA UDI
- 510(k) Number
- K935529 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 22 Millimeter FDA UDIDepth — 40 Millimeter FDA UDI
Category: Surgical retractor/retraction system blade, reusable
Black Belt Blunt Ti Blade by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Medfix — Medfix International, LLC · Class I
- DELACROIX-CHEVALIER — LANDANGER · Class I
- MSI — Modern Surgical Instruments LLC · Class I
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medfix — Medfix International, LLC · Class I
- CANYON™ Retractor Systems — K2M, INC. · Class I
Cleared under the same submission
K935529 also covers:
- Bea Style Blunt Ti Blade — Koros USA, Inc.
- Bea Style Pronged Ti Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Cervical Retractor 70mm Spike Blade — Koros USA, Inc.
- Black Belt Cervical Retractor Basic Set All Titanium — Koros USA, Inc.
- Black Belt Cervical Retractor Spike Blade, 70mm — Koros USA, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI 66c69663-bb8f-445f-81e3-4ee94f473ab8 38 fields · synced May 30, 2026