FDA.reportPublic FDA data

Inrad

Primary DI
00817295020459
Brand
Inrad
Company
Inrad
Model
51019
Device description
"Cournand, 2-part, 19 ga, 2 1/8"" "
Published
2016-12-01
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812973000PERCUTANEOUS INTRODUCER COURNAND STYLEDip, Inc.1981-11-16DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817295020456PackageGS120In Commercial Distribution
00817295020459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081729502045610817295020456
00817295020459008172950204598172950204590817295020459

Contacts#

Phone, Email table
PhoneEmail
6163017800sales@inradinc.com

Regulatory Flags#

DUNS number
940023385
Device count
1
Lot or batch
true
Expiration date on label
true

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
00884450839355Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-04
06954615625766Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626572Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626589Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626596Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626602Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
00884450838228Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-03
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24