FDA.reportPublic FDA data

Dilator

Primary DI
00841268100305
Brand
Dilator
Company
GALT MEDICAL CORP.
Model
DIL-601-05
Catalog number
DIL-601-05
Device description
Dilator
Published
2017-03-20
Public version status
Update
Distribution status
Not 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
10841268100302PackageGS110Not in Commercial Distribution
20841268100309PackageGS1100Not in Commercial Distribution
00841268100305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810030210841268100302
2084126810030920841268100309
00841268100305008412681003058412681003050841268100305

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

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
00841268110397Transcarotid/Peripheral Access KitKIT-075-05KIT-075-052026-08-18
00841268100015Tearaway Introducer KitKIT-064-07KIT-064-072018-02-06
00841268100022Tearaway Introducer KitKIT-064-08KIT-064-082018-02-06
00841268100039Tearaway Introducer KitKIT-064-09KIT-064-092018-02-06
00841268100046Tearaway Introducer KitKIT-064-10KIT-064-102018-02-06
00841268100053Tearaway Introducer KitKIT-064-11KIT-064-112018-02-06
00841268100060Tearaway Introducer KitKIT-064-12KIT-064-122018-02-06
00841268100213DilatorDIL-600-11DIL-600-112017-03-20
00841268100220DilatorDIL-600-12DIL-600-122017-03-20
00841268100237DilatorDIL-600-125DIL-600-1252017-03-20
00841268100244DilatorDIL-600-13DIL-600-132017-03-20
00841268100251DilatorDIL-600-14DIL-600-142017-03-20
00841268100268DilatorDIL-600-15DIL-600-152017-03-20
00841268100275DilatorDIL-600-16DIL-600-162017-03-20
00841268100282DilatorDIL-601-03DIL-601-032017-03-20
00841268100299DilatorDIL-601-04DIL-601-042017-03-20
00841268100312DilatorDIL-601-06DIL-601-062017-03-20
00841268100329DilatorDIL-601-07DIL-601-072017-03-20
00841268100336DilatorDIL-601-08DIL-601-082017-03-20
00841268100343DilatorDIL-615-29DIL-615-292017-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24