Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Curved Flat Blade Wood’s Retractor with contoured tip and handle, overall length 29 cm (11.5"), 12mm (0.47") width. Autoclavable Medical Grade Stainless Steel hardened to specifications FDA UDI
- Model / Reference
- 33-18-0116-01 FDA UDI
- Description
- Curved Flat Blade Wood’s Retractor with contoured tip and handle, overall length 29 cm (11.5"), 12mm (0.47") width. Autoclavable Medical Grade Stainless Steel hardened to specifications FDA UDI
Identifiers
- Primary DI / UDI-DI
- G45333180116010 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
No
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
No
FDA UDI
Serial Number
No
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
Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Specula Retractor Set — Koros USA, Inc. · Class I
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
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI 3e763613-b52b-4053-ac77-b460ce387ef2 33 fields · synced May 30, 2026