FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489111170
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
STGWLR2535NT
Catalog number
STGWLR2535NT
Device description
STERILE GUIDEWIRE, .025X35, NT
Published
2021-07-18
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
OFDCatheter introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFDCatheter Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489111177PackageGS110In Commercial Distribution
10193489111170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348911117720193489111177
1019348911117010193489111170

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 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160386315MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-14
10653160386278MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
10653160386285MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
10653160381983MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
10653160381990MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
10653160381808MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-10-28
10653160366577MEDLINEMEDLINE INDUSTRIES, INC.OFD2023-09-28
10653160351825MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
10653160351924MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
10653160350705MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
10653160350729MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
10653160349402MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349488CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-12-16
10653160348740MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-11-05
10653160348382MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-10-01
10193489111132MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111149MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111156MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111163MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10653160347767CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-07-13
10653160347422MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-06-02
10653160347026MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347033MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347040MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347101MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347149MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347163MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347194MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160344551CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2020-09-02
10653160343806MEDLINEMEDLINE INDUSTRIES, INC.OFD2020-07-06