FDA.reportPublic FDA data

Tearaway Introducer Set

Primary DI
00841268101760
Brand
Tearaway Introducer Set
Company
GALT MEDICAL CORP.
Model
INT-105-09
Catalog number
INT-105-09
Device description
Tearaway Introducer Set
Published
2017-07-03
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268101767PackageGS110In Commercial Distribution
20841268101764PackageGS1100In Commercial Distribution
00841268101760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810176710841268101767
2084126810176420841268101764
00841268101760008412681017608412681017600841268101760

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
false
HCT/P
false
Kit
false
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
00849884007541VYGONVygon CorporationDYB2026-05-22
00849884007558VYGONVygon CorporationDYB2026-05-22
20886333227864V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.DYB2026-03-11
20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
20884450113992Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
20884450115804Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.DYB2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
20801902225362ARROWTELEFLEX INCORPORATEDDYB2026-02-17
20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13