FDA.reportPublic FDA data

Inrad

Primary DI
00817295020008
Brand
Inrad
Company
Inrad
Model
15423
Catalog number
15423
Device description
Aspiration Biopsy Needle 23ga x 2"
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896019000MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.Dlp, Inc.1990-01-03GAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817295020008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817295020008008172950200088172950200080817295020008

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use 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
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
00817295020015Inrad15425154252026-10-08
00817295020022Inrad54818541812026-10-08
00817295020039Inrad54820548202026-10-08
00817295020046Inrad54822548222026-10-08
00817295020053Inrad54720547202026-10-08
00817295020060Inrad54722547222026-10-08
00817295020077Inrad54922549222026-10-08
00817295020107Inrad53722537222026-10-08
00817295020114Inrad53922539222026-10-08
00817295020121Inrad53822538222026-10-08
00817295020152Inrad53820538202026-10-08
00817295020169Inrad53720537202026-10-08
00817295020176Inrad53818538182026-10-08
00817295021081Inrad6209166209162026-10-08
00817295021098Inrad6209186209182026-10-08
00817295021104Inrad6209206209202026-10-08
00817295021111Inrad6215166215162026-10-08
00817295021128Inrad6215186215182026-10-08
00817295021135Inrad6215206215202026-10-08
00817295021142Inrad6409146409142026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295020015InradInradGAA2026-10-08
00817295020022InradInradGAA2026-10-08
00817295020039InradInradGAA2026-10-08
00817295020046InradInradGAA2026-10-08
00817295020053InradInradGAA2026-10-08
00817295020060InradInradGAA2026-10-08
00817295020077InradInradGAA2026-10-08
00817295020107InradInradGAA2026-10-08
00817295020114InradInradGAA2026-10-08
00817295020121InradInradGAA2026-10-08
00817295020152InradInradGAA2026-10-08
00817295020169InradInradGAA2026-10-08
00817295020176InradInradGAA2026-10-08
10198956592919CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-29
10198956573604CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-25
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14