Identity
- Trade Name
- Automatic Cutting Needle FDA UDI
- Generic Name
- Prostate biopsy needle FDA UDI
- Device Name
- 18 ga (1.3mm) x 25 cm FDA UDI
- Model / Reference
- NAC-1825 ULTRA FDA UDI
- Description
- 18 ga (1.3mm) x 25 cm FDA UDI
Identifiers
- Catalog Number
- NAC-1825 ULTRA FDA UDI
- Primary DI / UDI-DI
- 00813079020981 FDA UDI
- 510(k) Number
- K982401 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Prostate biopsy needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
Category: Prostate biopsy needle
Automatic Cutting Needle by Remington Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostate biopsy needle.
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- BIOPSY NEEDLE — RIVERPOINT MEDICAL LLC · Class II
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Cleared under the same submission
K982401 also covers:
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
- Automatic Cutting Needle — REMINGTON MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remington Medical, Inc.
Sources (1)
- FDA UDI f5cb3c2b-a451-4608-8cff-87825c329f0d 37 fields · synced Jun 8, 2026