FDA.reportPublic FDA data

Tearaway Introducer Kit

Primary DI
00841268100008
Brand
Tearaway Introducer Kit
Company
GALT MEDICAL CORP.
Model
KIT-064-06
Catalog number
KIT-064-06
Device description
Tearaway Introducer Kit
Published
2018-02-06
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
OFLPercutaneous Sheath Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268100005PackageGS15In Commercial Distribution
20841268100002PackageGS150In Commercial Distribution
00841268100008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810000510841268100005
2084126810000220841268100002
00841268100008008412681000088412681000080841268100008

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customerservice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268100855GuidewireSGW-019-38SGW-019-382017-07-03
00841268100862GuidewireSGW-019-40SGW-019-402017-07-03
00841268100879GuidewireSGW-019-41SGW-019-412017-07-03
00841268100886GuidewireSGW-019-52SGW-019-522017-07-03
00841268100893GuidewireSGW-019-53SGW-019-532017-07-03
00841268100909GuidewireSGW-021-02SGW-021-022017-07-03
00841268100916GuidewireSGW-021-03SGW-021-032017-07-03
00841268100923GuidewireSGW-021-04SGW-021-042017-07-03
00841268100930GuidewireSGW-022-09SGW-022-092017-07-03
00841268100947GuidewireSGW-022-10SGW-022-102017-07-03
00841268100954GuidewireSGW-022-11SGW-022-112017-07-03
00841268100961GuidewireSGW-022-13SGW-022-132017-07-03
00841268100978GuidewireSGW-022-14SGW-022-142017-07-03
00841268100985GuidewireSGW-022-15SGW-022-152017-07-03
00841268100992GuidewireSGW-022-16SGW-022-162017-07-03
00841268101005GuidewireSGW-022-32SGW-022-322017-07-03
00841268101012GuidewireSGW-022-33SGW-022-332017-07-03
00841268101029GuidewireSGW-022-36SGW-022-362017-07-03
00841268101036Guidewire SGW-022-49SGW-022-492017-07-03
00841268101043GuidewireSGW-035-00SGW-035-002017-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050855808Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459000Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459010Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459020Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459150Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459160Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459170Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459180Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
10197106004050CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
00810050853774Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853804Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853811Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853842Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853460Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853491Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853514Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050851954Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-06-09
00812269033763Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269033800Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269032957Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032971Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032995Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033015Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033039Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033053Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033077Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033091Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033114Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033138Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033152Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18