Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- - Laser Suction Cannula, dual lumen, Over Under Smaller Channel for a laser fiber (on top) and Larger Channel for suction (on bottom), 5-1/2” Working Length, 50deg angled bend—Spec’s on file with Elmed FDA UDI
- Model / Reference
- ST13LLSMOU FDA UDI
- Description
- - Laser Suction Cannula, dual lumen, Over Under Smaller Channel for a laser fiber (on top) and Larger Channel for suction (on bottom), 5-1/2” Working Length, 50deg angled bend—Spec’s on file with Elmed FDA UDI
Identifiers
- Catalog Number
- ST13LLSMOU FDA UDI
- Primary DI / UDI-DI
- 00842180191457 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 421ca17e-3dc7-40e1-b253-72495e97f7e8 36 fields · synced May 31, 2026