Identity
- Trade Name
- Novo Surgical FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- 1x1 tooth biopsy forceps, w/ flushport, single action, spring loaded, fixed, , radel™ (insulated) shaft only, remainder matte, 17.0 mm jaw, 5.0 mm, 35.0 cm (includes tip) FDA UDI
- Model / Reference
- 9013-0153FSI FDA UDI
- Description
- 1x1 tooth biopsy forceps, w/ flushport, single action, spring loaded, fixed, , radel™ (insulated) shaft only, remainder matte, 17.0 mm jaw, 5.0 mm, 35.0 cm (includes tip) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842331118418 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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 — 35 Centimeter FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
Novo Surgical by Novo Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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 62e5fc93-ac5b-4336-b409-99ffd4afa268 35 fields · synced Jun 8, 2026