Identity
- Trade Name
- ELMED INCORPORATED FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Ossoff-Karlan Laser Style Micro Laryngeal Suction Probe with 10 x12mm Operating Platform, 7 Fr. dia. angled cannula with finger controlled suction, 22.5cm (8 7/8”) working length, ebonized black for laser application. FDA UDI
- Model / Reference
- 42-9217 FDA UDI
- Description
- Ossoff-Karlan Laser Style Micro Laryngeal Suction Probe with 10 x12mm Operating Platform, 7 Fr. dia. angled cannula with finger controlled suction, 22.5cm (8 7/8”) working length, ebonized black for laser application. FDA UDI
Identifiers
- Catalog Number
- 42-9217 FDA UDI
- Primary DI / UDI-DI
- 00198506074004 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- ENT surgical procedure kit, non-medicated, 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT surgical procedure kit, non-medicated, reusable
Elmed Incorporated by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT surgical procedure kit, non-medicated, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® MicroFrance® — Integra LifeSciences Production Corporation · 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 5ebce727-9b83-4b8e-a9a1-23a92cb38b5a 35 fields · synced Jun 8, 2026