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

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

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
00817295020442Inrad510182016-12-01
00817295020466Inrad521182016-12-01
00817295020473Inrad520182016-12-01
00817295020480Inrad524192016-12-01
00817295020497Inrad522192016-12-01
00817295020503Inrad521192016-12-01
00817295020510Inrad550182016-12-01
00817295020527Inrad570182016-12-01
00817295020534Inrad550192016-12-01
00817295020541Inrad570192016-12-01
00817295020596Inrad500182016-12-01
00817295020602Inrad500192016-12-01
00817295020619Inrad9910142016-12-01
00817295020626Inrad9910162016-12-01
00817295020633Inrad9910182016-12-01
00817295020640Inrad9910202016-12-01
00817295020657Inrad9915162016-12-01
00817295020664Inrad9915142016-12-01
00817295020671Inrad9915182016-12-01
00817295020688Inrad9915202016-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30