FDA.report

Tearaway Introducer Set

Primary DI
00841268101784
Brand
Tearaway Introducer Set
Company
GALT MEDICAL CORP.
Model
INT-105-15
Catalog number
INT-105-15
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

Related Records

Contact Domains

Product Codes

CodeName
DYBIntroducer, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841268101781PackageGS110In Commercial Distribution
20841268101788PackageGS1100In Commercial Distribution
00841268101784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810178110841268101781
2084126810178820841268101788
00841268101784008412681017848412681017840841268101784

GMDN Terms

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

TypeValueUnit
Catheter Gauge12.5French

Sterilization Methods

Method
Ethylene Oxide

Contacts

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

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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

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