Identity
- Trade Name
- Black Belt Legend Clearview Retractor Basic Set FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Black Belt Legend Clearview Retractor Basic Set, Consists of the Following: 1x 7320-22P - Korpectomy Retractor frame Right, 1x 7320-20P - Retractor frame Left, 1x 7320-30P - Retractor frame Offset, 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40T - Blade Inserting Clamp, 2x 7322-34T - Pronged Ti Blade 34mm, 2x 7322-40T - Pronged Ti Blade 40mm, 2x 7322-45T - Pronged Ti Blade 45mm, 2x 7322-50T - Pronged Ti Blade 50mm, 2x 7322-55T - Pronged Ti Blade 55mm, 2x 7322-60T - Pronged Ti Blade 60mm, 2x 7322-70T - Pronged Ti Blade 70mm, 2x 7324-34T - Blunt Ti Blade 34mm, 2x 7324-40T - Blunt Ti Blade 40mm, 2x 7324-45T - Blunt Ti Blade 45mm, 2x 7324-50T - Blunt Ti Blade 50mm, 2x 7324-55T - Blunt Ti Blade 55mm, 2x 7324-60T - Blunt Ti Blade 60mm, 2x 7324-70T - Blunt Ti Blade 70mm, 4x 7326-40T - Two-Level Ti Blade Pronged 40mm, 4x 7326-47T - Two-Level Ti Blade Pronged 47mm, 4x 7326-55T - Two-Level Ti Blade Pronged 55mm, 2x 7328-40T - Two-Level Ti Blade Blunt 40mm, 2x 7328-47T - Two-Level Ti Blade Blunt 47mm, 2x 7328-55T - Two-Level Ti Blade Blunt 55mm, 1x 7320-90T - Sterilizing Instrument Case with silicone pads FDA UDI
- Model / Reference
- 7320-00PC FDA UDI
- Description
- Black Belt Legend Clearview Retractor Basic Set, Consists of the Following: 1x 7320-22P - Korpectomy Retractor frame Right, 1x 7320-20P - Retractor frame Left, 1x 7320-30P - Retractor frame Offset, 1x 7320-35P - Black Belt Legend Screwdriver 2x 7320-40T - Blade Inserting Clamp, 2x 7322-34T - Pronged Ti Blade 34mm, 2x 7322-40T - Pronged Ti Blade 40mm, 2x 7322-45T - Pronged Ti Blade 45mm, 2x 7322-50T - Pronged Ti Blade 50mm, 2x 7322-55T - Pronged Ti Blade 55mm, 2x 7322-60T - Pronged Ti Blade 60mm, 2x 7322-70T - Pronged Ti Blade 70mm, 2x 7324-34T - Blunt Ti Blade 34mm, 2x 7324-40T - Blunt Ti Blade 40mm, 2x 7324-45T - Blunt Ti Blade 45mm, 2x 7324-50T - Blunt Ti Blade 50mm, 2x 7324-55T - Blunt Ti Blade 55mm, 2x 7324-60T - Blunt Ti Blade 60mm, 2x 7324-70T - Blunt Ti Blade 70mm, 4x 7326-40T - Two-Level Ti Blade Pronged 40mm, 4x 7326-47T - Two-Level Ti Blade Pronged 47mm, 4x 7326-55T - Two-Level Ti Blade Pronged 55mm, 2x 7328-40T - Two-Level Ti Blade Blunt 40mm, 2x 7328-47T - Two-Level Ti Blade Blunt 47mm, 2x 7328-55T - Two-Level Ti Blade Blunt 55mm, 1x 7320-90T - Sterilizing Instrument Case with silicone pads FDA UDI
Identifiers
- Catalog Number
- 7320-00PC FDA UDI
- Primary DI / UDI-DI
- 10840199504395 FDA UDI
- 510(k) Number
- K935529 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Self-retaining surgical retractor, 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
Yes
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
Category: Self-retaining surgical retractor, reusable
Black Belt Legend Clearview Retractor Basic Set by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, reusable.
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- SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, 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 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.
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 64da0f89-bbc2-4d95-820e-ba6b309992ab 37 fields · synced Jun 1, 2026