FDA.reportPublic FDA data

Inrad

Primary DI
10817295020883
Brand
Inrad
Company
Inrad
Model
601609
Device description
AccuCore Coaxial w/Hiliter 15 ga x 9 cm
Published
2016-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K981721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981721000C0-AXIAL INTRODUCER NEEDLEInrad1998-07-28KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817295020883PackageGS110In Commercial Distribution
00817295020886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081729502088310817295020883
00817295020886008172950208868172950208860817295020886

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6163017800sales@inradinc.com

Regulatory Flags#

DUNS number
940023385
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817295020138Inrad53222532222026-10-09
00817295020145Inrad53220532202026-10-09
00817295020183Inrad53218532182026-10-09
00817295020190Inrad41218412182026-10-09
00817295020206Inrad41220412202026-10-09
00817295020213Inrad41222412222026-10-09
00817295020220Inrad41820418202026-10-09
00817295020237Inrad41822418222026-10-09
00817295020244Inrad45118451182026-10-09
00817295020251Inrad45018450182026-10-09
00817295020268Inrad45120451202026-10-09
00817295020275Inrad45020450202026-10-09
00817295020282Inrad45222452222026-10-09
00817295020299Inrad45122451222026-10-09
00817295020305Inrad45022450222026-10-09
00817295020312Inrad54018540182026-10-09
00817295020329Inrad54118541182026-10-09
00817295020336Inrad54120541202026-10-09
00817295020343Inrad54020540202026-10-09
00817295020350Inrad54222542222026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295020589InradInradKNW2026-10-09
00817295021081InradInradKNW2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021388InradInradKNW2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15