Identity
- Trade Name
- RONGEUR FDA UDI
- Generic Name
- Craniofacial rongeur, reusable FDA UDI
- Device Name
- CUTTING, BONE, HAJEK, ANGLED UP, 4 X 4 MM JAWS FDA UDI
- Model / Reference
- 37-340-13-07 FDA UDI
- Description
- CUTTING, BONE, HAJEK, ANGLED UP, 4 X 4 MM JAWS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118059215 FDA UDI
- FDA Product Code
- KBB FDA UDI
- GMDN Term
- Craniofacial rongeur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Category: Craniofacial rongeur, reusable
Rongeur by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial rongeur, reusable.
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- Wiggins Medical — EBNER MEDICAL LLC · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Wiggins Medical — EBNER MEDICAL LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI 3617024b-5016-4df4-9aa3-1dd7b7f5b4a2 34 fields · synced Jun 8, 2026