Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Favaloro-Morse Sternal Retractor, Short, Stainless Steel, Spread 8" (20CM), Side of blades 1-1/8" (2.8cm) wide; 1-1/2" (3.8CM) deep, Overall Arm Length 6" (15.2CM) working Arm Length 4.5" (11.4CM). FDA UDI
- Model / Reference
- PM57246-21 FDA UDI
- Description
- Favaloro-Morse Sternal Retractor, Short, Stainless Steel, Spread 8" (20CM), Side of blades 1-1/8" (2.8cm) wide; 1-1/2" (3.8CM) deep, Overall Arm Length 6" (15.2CM) working Arm Length 4.5" (11.4CM). FDA UDI
Identifiers
- Primary DI / UDI-DI
- G453PM57246210 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
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
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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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 03b3b5ae-9046-44e2-8930-be2aae482211 33 fields · synced May 30, 2026