Identity
- Trade Name
- Greenwald Surgical Company, Inc. FDA UDI
- Generic Name
- Urethrotome FDA UDI
- Device Name
- Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainless steel straight blade. Distal stabilization for proper alignment with telescope. Compatible with ACMI USA/Elite visual urethrotome. FDA UDI
- Model / Reference
- 50510-00 FDA UDI
- Description
- Visual Urethrotome Cold Knife. Hardened and precision ground ultra-sharp stainless steel straight blade. Distal stabilization for proper alignment with telescope. Compatible with ACMI USA/Elite visual urethrotome. FDA UDI
Identifiers
- Catalog Number
- U467VS FDA UDI
- Primary DI / UDI-DI
- 10801334005542 FDA UDI
- FDA Product Code
- EZO FDA UDI
- GMDN Term
- Urethrotome FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4770 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urethrotome
Greenwald Surgical Company, Inc. by Grace Manufacturing Inc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Grace Manufacturing Inc
Sources (1)
- FDA UDI 2945c3d0-ff7c-4a8e-b746-dfa688e8b705 34 fields · synced May 30, 2026