FDA.reportPublic FDA data

Inrad

Primary DI
00817295020190
Brand
Inrad
Company
Inrad
Model
41218
Catalog number
41218
Device description
HiLiter Ultrasound Enhanced Sharp Bevel Asp. Needle, 18 ga x 6 cm
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
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
K813368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K813368000DISPOSABLE CHIBA-TYPE NEEDLEDlp, Inc.1982-01-05GAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817295020190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817295020190008172950201908172950201900817295020190

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
00817295020138Inrad53222532222026-10-09
00817295020145Inrad53220532202026-10-09
00817295020183Inrad53218532182026-10-09
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
00817295020367Inrad54122541222026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09
00817295020374InradInradGAA2026-10-09
00817295020381InradInradGAA2026-10-09
00817295020398InradInradGAA2026-10-09
00817295020404InradInradGAA2026-10-09
00817295020411InradInradGAA2026-10-09
00817295020428InradInradGAA2026-10-09
00817295020435InradInradGAA2026-10-09
08800165015435ACE CANNULAACE MEDICAL INDUSTRY CO., LTD.GAA2026-10-09
00817295020008InradInradGAA2026-10-08
00817295020015InradInradGAA2026-10-08