Identity
- Trade Name
- Greenwald Surgical Company, Inc. FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Teflon insulation. Tungsten alloy cutting wire. Resectoscope Cutting Loop. Compatible with ACMI USA/Elite adult resectoscopes. FDA UDI
- Model / Reference
- 33601-12 FDA UDI
- Description
- Teflon insulation. Tungsten alloy cutting wire. Resectoscope Cutting Loop. Compatible with ACMI USA/Elite adult resectoscopes. FDA UDI
Identifiers
- Catalog Number
- U433RS FDA UDI
- Primary DI / UDI-DI
- 10801334013035 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Angle — 80 degree FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
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 f77f0dbf-25cf-4dd1-93d7-a07b2239d100 35 fields · synced May 30, 2026