Identity
- Trade Name
- Moving-shot guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Needle guide FDA UDI
- Model / Reference
- NGL18-E-LA522 FDA UDI
- Description
- Needle guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809295149966 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
Category: Needle guide, single-use
Moving-shot guide by RF Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
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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 II | Pending data |
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Manufacturer
- Manufacturer
- RF Medical Co., Ltd.
Sources (1)
- FDA UDI d405e7b8-3630-48ca-8efe-4a80b1d5bae6 35 fields · synced May 30, 2026