Identity
- Trade Name
- NOVO Surgical FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Tenzel Bipolar Forceps, w/ stop, 0.5 mm tip, curved arc, 4" (10.0 cm), insulated w/ irrigation FDA UDI
- Model / Reference
- G1911-14IG FDA UDI
- Description
- Tenzel Bipolar Forceps, w/ stop, 0.5 mm tip, curved arc, 4" (10.0 cm), insulated w/ irrigation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842331184147 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, 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
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
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
NOVO Surgical by Novo Surgical, 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
- Novo Surgical, Inc.
Sources (1)
- FDA UDI f034a3d7-2d0b-4a76-b7a8-9d2f8cabe945 35 fields · synced May 30, 2026