Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Craniofacial rongeur, reusable FDA UDI
- Device Name
- KERRISON RONGEUR, MICRO, 8" (200 MM) 3MM, 40 DEG UP PIN EJECTOR, SUPER COAT FDA UDI
- Model / Reference
- SC8-3MM40PIN FDA UDI
- Description
- KERRISON RONGEUR, MICRO, 8" (200 MM) 3MM, 40 DEG UP PIN EJECTOR, SUPER COAT FDA UDI
Identifiers
- Catalog Number
- SC8-3MM40PIN FDA UDI
- Primary DI / UDI-DI
- 00842180184879 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Craniofacial rongeur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial rongeur, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial rongeur, reusable.
- IVD Rongeur — Koros USA, Inc. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- 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
- BEAR — Bear-Ent, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elmed Incorporated
Sources (1)
- FDA UDI d5c69ba7-655a-4885-b899-6dbfa082940a 35 fields · synced May 30, 2026