Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Body aspiration needle, reusable FDA UDI
- Device Name
- FRAZIER VENTR CANNULA 12GA 3-1/2IN FDA UDI
- Model / Reference
- 45-2122NL FDA UDI
- Description
- FRAZIER VENTR CANNULA 12GA 3-1/2IN FDA UDI
Identifiers
- Catalog Number
- 45-2122NL FDA UDI
- Primary DI / UDI-DI
- 00198506058707 FDA UDI
- FDA Product Code
- HCD FDA UDI
- GMDN Term
- Body aspiration needle, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4060 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: Body aspiration needle, reusable
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
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 d63de412-5b40-4b0d-af6a-5ffe68bec88b 35 fields · synced May 31, 2026