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Stainless Steel Cardiac 3 Finger Heart Retractor - Large
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Stainless Steel Cardiac 3 Finger Heart Retractor - Large FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Stainless Steel Cardiac 3 Finger Heart Retractor - Heart Assist, Single Use, 3 Finger Short, Malleable 60mm x 54mm L FDA UDI
- Model / Reference
- HAF3SHS FDA UDI
- Description
- Stainless Steel Cardiac 3 Finger Heart Retractor - Heart Assist, Single Use, 3 Finger Short, Malleable 60mm x 54mm L FDA UDI
Identifiers
- Primary DI / UDI-DI
- B354HAF3SHS1 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Peracetic Acid FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusableEndoscopic electrosurgical electrode, monopolar, single-use
Stainless Steel Cardiac 3 Finger Heart Retractor - Large by Orange Surgical Instruments, Llc — Class II — FDA UDI — listed in FDA GUDID
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Orange Surgical Instruments, Llc
Sources (1)
- FDA UDI 9224f28e-08e8-4203-9dc0-7e66e955d1d4 33 fields · synced May 30, 2026