FDA.reportPublic FDA data

Valved Tearaway Kit

Primary DI
20841268108237
Brand
Valved Tearaway Kit
Company
GALT MEDICAL CORP.
Model
KIT-077-05
Catalog number
KIT-077-05
Device description
Valved Tearaway Kit
Published
2018-05-23
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
10841268108230PackageGS15In Commercial Distribution
20841268108237PackageGS150In Commercial Distribution
00841268108233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810823010841268108230
2084126810823720841268108237
00841268108233008412681082338412681082330841268108233

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 Gauge5French

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
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
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00810050853514Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
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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