FDA.report

MEDLINE

Primary DI
10653160349679
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
NITGW3260ST
Catalog number
NITGW3260ST
Device description
GUIDEWIRE - NITINOL CORE .032X60CM 3MMJ
Published
2021-12-23
Public version status
New
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
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
OFDCatheter introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2
OFDCatheter Introducer KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160349679PackageGS110In Commercial Distribution
20653160349676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1065316034967910653160349679
2065316034967620653160349676

GMDN Terms

TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20801902219385ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30801902219405ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219415ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219460ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219484ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
20801902219514ARROWTELEFLEX INCORPORATEDFOZ2026-03-24
30197344181517MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344181527MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20197344199690MEDLINEMEDLINE INDUSTRIES, INC.FOZ2026-03-13
20801902225478ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225485ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225492ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
20801902225539ARROWTELEFLEX INCORPORATEDFOZ2026-03-11
30801902219375ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219392ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219422ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219439ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219446ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219453ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219477ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219491ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219507ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219521ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219538ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219545ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219569ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219576ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219583ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
20801902219590ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
30382903836483NexivaBECTON, DICKINSON AND COMPANYFOZ2026-02-17