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Black Belt II Retractor Frame, Offset with Tilting Arm, Stainless Steel
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Black Belt II Retractor Frame, Offset with Tilting Arm, Stainless Steel FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Black Belt II Retractor Frame, Offset with Tilting Arm, Stainless Steel FDA UDI
- Model / Reference
- 7320-30U FDA UDI
- Description
- Black Belt II Retractor Frame, Offset with Tilting Arm, Stainless Steel FDA UDI
Identifiers
- Catalog Number
- 7320-30U FDA UDI
- Primary DI / UDI-DI
- 10840199502278 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
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
Category: Self-retaining surgical retractor, reusable
Black Belt II Retractor Frame, Offset with Tilting Arm, Stainless Steel by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Self-retaining surgical retractor, reusable.
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
- Life Instruments — Life Instrument Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- 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 452ed1d2-c47e-438c-803e-ffff9a843510 37 fields · synced Jun 8, 2026