Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- FIBEROPTIC CABLE WITH UNIVERSAL SCOPE & LIGHT SOURCE CONNECTORS (PILLING SCOPE & ACMI LIGHT SOURCE), NON-RETURNABLE FDA UDI
- Model / Reference
- 9820PA FDA UDI
- Description
- FIBEROPTIC CABLE WITH UNIVERSAL SCOPE & LIGHT SOURCE CONNECTORS (PILLING SCOPE & ACMI LIGHT SOURCE), NON-RETURNABLE FDA UDI
Identifiers
- Catalog Number
- 9820PA FDA UDI
- Primary DI / UDI-DI
- 00198506058905 FDA UDI
- FDA Product Code
- EQH FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4350 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fibreoptic light cable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
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- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- FENTEX — FENTEX medical GmbH · 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
- Elmed Incorporated
Sources (1)
- FDA UDI cf6f58ab-27d7-40ba-84ec-71306e5d0691 35 fields · synced May 30, 2026