FDA.reportPublic FDA data

Inrad

Primary DI
00817295020589
Brand
Inrad
Company
Inrad
Model
54501
Catalog number
54501
Device description
Aspiration Biopsy Syringe Gun
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K913098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913098000APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501Dlp, Inc.1991-11-05KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817295020589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817295020589008172950205898172950205890817295020589

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy syringe holder, reusableA hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.

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
true
Expiration date on label
false
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
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
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15