FDA.reportPublic FDA data

4F STIFF Micro-Stick® INTRODUCER SET WITH NITINOL GUIDEWIRE

Primary DI
00810988020170
Brand
4F STIFF Micro-Stick® INTRODUCER SET WITH NITINOL GUIDEWIRE
Company
JET MEDICAL, INC.
Model
JT100400001
Catalog number
JT100400001
Published
2015-07-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
30810988020171PackageGS15In Commercial Distribution
50810988020175PackageGS15In Commercial Distribution
00810988020170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081098802017130810988020171
5081098802017550810988020175
00810988020170008109880201708109880201700810988020170

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18663854047customerservice@jetmedicalinc.com

Regulatory Flags#

DUNS number
079506014
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081098802095812F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314012012017-06-20
0081098802096512F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314015012017-06-20
0081098802098912F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314024012017-06-20
0081098802097212 F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE)JT0314020012017-06-20
0081098802000215.5F X 24CM JET FLOW LT CATHETERJT011552401JT0115524012015-07-20
0081098802001915.5F X 28CM JET FLOW LT CATHETERJT011552801JT0115528012015-07-20
0081098802002615.5F X 32CM JET FLOW LT CATHETERJT011553201JT0115532012015-07-20
0081098802003315.5F X 36CM JET FLOW LT CATHETERJT011553601JT0115536012015-07-20
0081098802004015.5F X 55CM JET FLOW LT CATHETERJT011555501JT0115555012015-07-20
0081098802005715.5F X 24CM JET FLOW PRE-CURVED LT CATHETERJT021552401JT0215524012015-08-25
0081098802006415.5F X 28CM JET FLOW PRE-CURVED LT CATHETERJT021552801JT0215528012015-07-20
0081098802007115.5F X 32CM JET FLOW PRE-CURVED LT CATHETERJT021553201JT0215532012015-08-25
0081098802008815.5F X 36CM JET FLOW PRE-CURVED LT CATHETERJT021553601JT0215536012015-07-20
008109880205833F X 55CM SINGLE LUMEN POWER PICCJT05035501JT050355012015-07-20
008109880205904F X 55CM SINGLE LUMEN POWER PICCJT05045501JT050455012015-07-20
008109880206065F X 55CM DOUBLE LUMEN POWER PICCJT06055501JT060555012015-07-20
008109880206514F STIFF COAXIAL DILATORJT120400000JT1204000002015-07-20
008109880206685F STIFF COAXIAL DILATORJT120500000JT1205000002015-07-20
008109880206824F REGULAR COAXIAL DILATORJT130400000JT1304000002015-07-20
008109880206995F REGULAR COAXIAL DILATORJT130500000JT1305000002015-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355120ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355130ENVINAVILYST MEDICAL, INC.DYB2017-08-07