FDA.report

Micro-Intoducer Kit

Primary DI
20841268104635
Brand
Micro-Intoducer Kit
Company
GALT MEDICAL CORP.
Model
KIT-002-03
Catalog number
KIT-002-03
Device description
Micro-Intoducer Kit
Published
2018-01-04
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
OFLPercutaneous Sheath Introducer Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841268104638PackageGS110In Commercial Distribution
20841268104635PackageGS1100In Commercial Distribution
00841268104631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810463810841268104638
2084126810463520841268104635
00841268104631008412681046318412681046310841268104631

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 Gauge5French

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
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

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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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Primary DIBrandCompanyProduct codePublished
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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