Identity
- Trade Name
- Specula Retractor Set FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Lumbar Micro Disc Specula Retractor Set Consists of the Following: 1 x 7270-40 Lumbar Micro Discectomy Specula Retractor 40mm, 1 x 7270-45 Lumbar Micro Discectomy Specula Retractor 45mm, 1 x 7270-50 Lumbar Micro Discectomy Specula Retractor 50mm, 1 x 7270-55 Lumbar Micro Discectomy Specula Retractor 55mm, 1 x 7270-60 Lumbar Micro Discectomy Specula Retractor 60mm, 1 x 7272-20 Micro Discectomy Specula Cross Retractor Frame Only, 1 x 7272-40 Micro Discectomy Blade 40mm Deep, 1 x 7272-45 Micro Discectomy Blade 45mm Deep, 1 x 7272-50 Micro Discectomy Blade 50mm Deep, 1 x 7272-55 Micro Discectomy Blade 55mm Deep, 1 x 7272-60 Micro Discectomy Blade 60mm Deep, 1 x 7272-65 Micro Discectomy Blade 65mm Deep & 1 x 7268-80 Blade Ejector FDA UDI
- Model / Reference
- 7271-00 FDA UDI
- Description
- Lumbar Micro Disc Specula Retractor Set Consists of the Following: 1 x 7270-40 Lumbar Micro Discectomy Specula Retractor 40mm, 1 x 7270-45 Lumbar Micro Discectomy Specula Retractor 45mm, 1 x 7270-50 Lumbar Micro Discectomy Specula Retractor 50mm, 1 x 7270-55 Lumbar Micro Discectomy Specula Retractor 55mm, 1 x 7270-60 Lumbar Micro Discectomy Specula Retractor 60mm, 1 x 7272-20 Micro Discectomy Specula Cross Retractor Frame Only, 1 x 7272-40 Micro Discectomy Blade 40mm Deep, 1 x 7272-45 Micro Discectomy Blade 45mm Deep, 1 x 7272-50 Micro Discectomy Blade 50mm Deep, 1 x 7272-55 Micro Discectomy Blade 55mm Deep, 1 x 7272-60 Micro Discectomy Blade 60mm Deep, 1 x 7272-65 Micro Discectomy Blade 65mm Deep & 1 x 7268-80 Blade Ejector FDA UDI
Identifiers
- Catalog Number
- 7271-00 FDA UDI
- Primary DI / UDI-DI
- 10840199543400 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable 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
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
Yes
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: Surgical retractor/retraction system blade, reusable
Specula Retractor Set by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI 48508253-a889-4e29-b395-f7d001bdae52 37 fields · synced May 31, 2026