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Remington Medical, Inc. Automatic Cutting Needle (NAC)
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref NAC-1625MModel Automatic Cutting Needle (NAC)
Identity
- Trade Name
- Remington Medical, Inc. Automatic Cutting Needle (NAC) EUDAMEDFDA UDI
- Generic Name
- End-cut biopsy gun needle FDA UDI
- Device Name
- Automatic Cutting Needle (NAC) EUDAMEDAutomatic Cutting Needles (NAC) for Biopsy 16 ga x 25 cm FDA UDI
- Model / Reference
- Automatic Cutting Needle (NAC) EUDAMEDNAC-1625M EUDAMEDFDA UDI
- Description
- Automatic Cutting Needles (NAC) for Biopsy 16 ga x 25 cm FDA UDI
Identifiers
- Catalog Number
- NAC-1625M FDA UDI
- Primary DI / UDI-DI
- 00813079022176 EUDAMEDFDA UDI
- Basic UDI-DI
- 081307902NACC5 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- End-cut biopsy gun needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Centimeter FDA UDI
Remington Medical, Inc. Automatic Cutting Needle (NAC) by Remington Medical, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191315 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081307902NACC5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Remington Medical, Inc.
- EUDAMED SRN
- US-MF-000002612
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ba1cc993-0193-419c-8387-08d0676c107e 61 fields · synced Jun 18, 2026
- FDA UDI 577ae61d-ba3c-4e2f-82ca-269f821c4f10 36 fields · synced May 30, 2026
- FDA 510(k) K191315 1 fields · synced May 18, 2026