FDA.reportPublic FDA data

Tearaway Introducer Kit

Primary DI
00841268100022
Brand
Tearaway Introducer Kit
Company
GALT MEDICAL CORP.
Model
KIT-064-08
Catalog number
KIT-064-08
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
OTC
false
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
10841268100029PackageGS15In Commercial Distribution
20841268100026PackageGS150In Commercial Distribution
00841268100022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810002910841268100029
2084126810002620841268100026
00841268100022008412681000228412681000220841268100022

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841268110397Transcarotid/Peripheral Access KitKIT-075-05KIT-075-052026-08-18
00841268100015Tearaway Introducer KitKIT-064-07KIT-064-072018-02-06
00841268100039Tearaway Introducer KitKIT-064-09KIT-064-092018-02-06
00841268100046Tearaway Introducer KitKIT-064-10KIT-064-102018-02-06
00841268100053Tearaway Introducer KitKIT-064-11KIT-064-112018-02-06
00841268100060Tearaway Introducer KitKIT-064-12KIT-064-122018-02-06
00841268100213DilatorDIL-600-11DIL-600-112017-03-20
00841268100220DilatorDIL-600-12DIL-600-122017-03-20
00841268100237DilatorDIL-600-125DIL-600-1252017-03-20
00841268100244DilatorDIL-600-13DIL-600-132017-03-20
00841268100251DilatorDIL-600-14DIL-600-142017-03-20
00841268100268DilatorDIL-600-15DIL-600-152017-03-20
00841268100275DilatorDIL-600-16DIL-600-162017-03-20
00841268100282DilatorDIL-601-03DIL-601-032017-03-20
00841268100299DilatorDIL-601-04DIL-601-042017-03-20
00841268100305DilatorDIL-601-05DIL-601-052017-03-20
00841268100312DilatorDIL-601-06DIL-601-062017-03-20
00841268100329DilatorDIL-601-07DIL-601-072017-03-20
00841268100336DilatorDIL-601-08DIL-601-082017-03-20
00841268100343DilatorDIL-615-29DIL-615-292017-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050855808Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
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
00810050853538Typenex 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 SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269032971Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269032995Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033015Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033039Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033053Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033077Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033091Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033114Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033138Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033152Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00841268105744Micro-Introducer Kit with Side-HolesGALT MEDICAL CORP.OFL2018-02-07
00841268105751Micro-Introducer Kit with Side-HolesGALT MEDICAL CORP.OFL2018-02-07
00841268100015Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100039Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100046Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100053Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06
00841268100060Tearaway Introducer KitGALT MEDICAL CORP.OFL2018-02-06