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Remington Medical, Inc. Automatic Cutting Needle (NAC)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NAC-2016MLLModel 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-MLL) 20 ga x 16 cm FDA UDI
- Model / Reference
- Automatic Cutting Needle (NAC) EUDAMEDNAC-2016MLL EUDAMEDFDA UDI
- Description
- Automatic Cutting Needles (NAC-MLL) 20 ga x 16 cm FDA UDI
Identifiers
- Catalog Number
- NAC-2016MLL FDA UDI
- Primary DI / UDI-DI
- 00813079022589 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 — 16 Centimeter FDA UDI
Remington Medical, Inc. Automatic Cutting Needle (NAC) by Remington Medical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081307902NACC5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Remington Medical, Inc.
- EUDAMED SRN
- US-MF-000002612
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1301a80c-a898-4f8c-9d6f-35f4ae171ae1 61 fields · synced Jun 18, 2026
- FDA UDI 69c44074-31cb-4acc-9391-5020333d0d0b 36 fields · synced May 27, 2026