FDA.reportPublic FDA data

Automatic Cutting Needle

Primary DI
00813079020899
Brand
Automatic Cutting Needle
Company
REMINGTON MEDICAL, INC.
Model
NAC-1816BB
Catalog number
NAC-1816BB
Device description
18 ga (1.3mm) x 16 cm
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982401000PROSTATE BIOPSY NEEDLERemington Medical, Inc.1998-09-08KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020896PackageGS110In Commercial Distribution
20813079020893PackageGS110In Commercial Distribution
00813079020899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902089610813079020896
2081307902089320813079020893
00813079020899008130790208998130790208990813079020899

GMDN Terms#

Term, Definition table
TermDefinition
Prostate biopsy needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a prostatic tissue specimen typically for histopathological examination. It is available in various diameters and has a distal tip that may be configured in various geometric forms. It is commonly used during a transrectal ultrasound (TRUS) scan. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813079021506Remington Medical, Inc Disposable Extension CablePK-155-BPK-155-B2026-04-10
00813079022664VascuChek TransceiverVC-TRX-02VC-TRX-022025-11-27
00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
00813079022008Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022015Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412BNAC-1412B2025-01-17
00813079022022Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416BNAC-1416B2025-01-17
00813079022039Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420BNAC-1420B2025-01-17
00813079022046Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610BNAC-1610B2025-01-17
00813079022053Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616BNAC-1616B2025-01-17
00813079022060Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1620BNAC-1620B2025-01-17
00813079022077Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1810BNAC-1810B2025-01-17
00813079022084Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416NAC-14162025-01-17
00813079022091Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1825NAC-18252025-01-17
00813079022107Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022114Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412MNAC-1412M2025-01-17
00813079022121Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416MNAC-1416M2025-01-17
00813079022138Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420MNAC-1420M2025-01-17
00813079022145Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610MNAC-1610M2025-01-17
00813079022152Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616MNAC-1616M2025-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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