Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Two Piece Compression Style Stainless Steel Custom Manifold Holder 2.25" X 1.12" X 1.5" with 120 degree 8MM deep "V" rear inset. Detachable 0.24" X 2.25" X 1/4" ribbon fitted with 1-1/4" long screws. Single Round Screw rod Adjustments fitted for friction crimp manifold compression. FDA UDI
- Model / Reference
- 33-1095BC FDA UDI
- Description
- Two Piece Compression Style Stainless Steel Custom Manifold Holder 2.25" X 1.12" X 1.5" with 120 degree 8MM deep "V" rear inset. Detachable 0.24" X 2.25" X 1/4" ribbon fitted with 1-1/4" long screws. Single Round Screw rod Adjustments fitted for friction crimp manifold compression. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G453331095BC0 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A comprehensive hand-operated, self-retaining, one-piece surgical instrument for separating/draw aside wound/incision margins during open surgery.
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 aabae4e6-5b04-4209-942d-ccda86c5e923 34 fields · synced Jul 18, 2026