FDA.reportPublic FDA data

NiCore Nitinol Guidewire

Primary DI
00801741051487
Brand
NiCore Nitinol Guidewire
Company
C. R. Bard, Inc.
Model
150NFS35
Catalog number
150NFS35
Device description
"NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Straight Tip, 0.035""(0.888mm) x 150cm"
Published
2020-09-23
Public version status
Update
Distribution status
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
EZBSTYLET FOR CATHETER, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741051484PackageGS110In Commercial Distribution
00801741051487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105148410801741051484
00801741051487008017410514878017410514870801741051487

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter
Outer Diameter0.035Inch

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421267MillenniumAvalign Technologies, Inc.EZB2026-05-04
00190776415419MillenniumAvalign Technologies, Inc.EZB2026-01-27
00190776389789MillenniumAvalign Technologies, Inc.EZB2024-11-18
00190776307356MillenniumAvalign Technologies, Inc.EZB2023-11-17
00190776303020MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776303341MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776302016MillenniumAvalign Technologies, Inc.EZB2023-11-15
00810143901191SURGIPROSSurgipros, LLCEZB2023-09-08
00190776350710MillenniumAvalign Technologies, Inc.EZB2023-01-10
00190776296933MillenniumAvalign Technologies, Inc.EZB2022-12-12
00190776163730MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163747MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163754MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163761MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163778MillenniumAvalign Technologies, Inc.EZB2021-11-01
00827002448469Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448483Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448490Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448551Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00801741051449NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051456NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051463NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051470NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051494NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051500NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051517NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051524NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051531NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
10801741051446NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
10801741051453NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23