Identity
- Trade Name
- Lorad Needle Guide EUDAMEDNeedle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Lorad Needle Guide EUDAMEDNeedle Guide for Lorad Stereo Loc for 20ga-22ga FDA UDI
- Model / Reference
- LNGC2022YX EUDAMEDFDA UDI
- Description
- Needle Guide for Lorad Stereo Loc for 20ga-22ga FDA UDI
Identifiers
- Catalog Number
- LNGC2022YX FDA UDI
- Primary DI / UDI-DI
- 20886333001679 EUDAMED00886333001675 FDA UDI
- Basic UDI-DI
- B-20886333001679 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, single-use
Needle Guide by Argon Medical Devices, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI f9a4f145-0af1-4dcb-9449-bb86a3cf7d79 37 fields · synced Jul 8, 2026
- EUDAMED cc23dee9-4cbb-4ed2-ae21-1b57df3dd7cf 61 fields · synced Jul 8, 2026