FDA.reportPublic FDA data

Tearaway Introducer Kit

Primary DI
20841268100033
Brand
Tearaway Introducer Kit
Company
GALT MEDICAL CORP.
Model
KIT-064-09
Catalog number
KIT-064-09
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
10841268100036PackageGS15In Commercial Distribution
20841268100033PackageGS150In Commercial Distribution
00841268100039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810003610841268100036
2084126810003320841268100033
00841268100039008412681000398412681000390841268100039

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 Gauge9French

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
10841268108353Quiktork Guidewire Torque DeviceTOR-100-10TOR-100-102026-02-25
10841268108360Quiktork Guidewire Torque DeviceTOR-100-25TOR-100-252026-02-25
10841268110059Micro-Introducer KitKIT-100-00KIT-100-002026-01-19
10841268110066GuidewireSGW-071-01SGW-071-012026-01-19
10841268110073Hemostasis Valve AdapterGWT-001-00GWT-001-002026-01-19
10841268110080GuidewireSGW-074-00SGW-074-002026-01-19
10841268110097TVS LPAKIT-071-13LPA430SNS2026-01-19
10841268110110GuidewireSGW-071-02SGW-071-022026-01-19
10841268110127TVS LPAKIT-071-14KIT-071-142026-01-19
10841268110141DilatorDIL-616-08DIL-616-082026-01-19
10841268110332DilatorDIL-502-06DIL-502-062026-01-19
10841268110349Micro-Introducer KitKIT-100-01KIT-100-012026-01-19
10841268110356GuidewireSGW-071-03SGW-071-032026-01-19
10841268110363GuidewireSGW-022-69SGW-022-692026-01-19
10841268110387Micro-Introducer KitKIT-100-02KIT-100-022026-01-19
10841268110134GuidewireSGW-075-01BMG013-300DT2024-08-01
10841268109800Elite Transitionless Micro-Introducer KitKIT-098-01KIT-098-012022-08-15
10841268109817Elite Transitionless Micro-Introducer KitKIT-098-02KIT-098-022022-08-15
10841268109824Elite Transitionless Micro-Introducer KitKIT-098-03KIT-098-032022-08-15
10841268109831Elite Transitionless Micro-Introducer KitKIT-098-04KIT-098-042022-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841268110059Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110097TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110127TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110349Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110387Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10810050855805Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459001Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459011Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459021Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459151Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459161Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459171Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459181Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
20886333227550ClosureFast Micro Puncture ARGON MEDICAL DEVICES, INC.OFL2024-07-29
20886333227567ClosureFast Micro PunctureARGON MEDICAL DEVICES, INC.OFL2024-07-29
50197106004058CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
10841268109800Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109817Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109824Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109831Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109848Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109855Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109862Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109879Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109886Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109893Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109909Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109916Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109923Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109930Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15