FDA.reportPublic FDA data

Centurion

Primary DI
10653160349662
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
NITGW3245ST
Catalog number
NITGW3245ST
Device description
GUIDEWIRE - NITINOL CORE .032X45CM 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

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
10653160349662PackageGS110In Commercial Distribution
20653160349669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316034966210653160349662
2065316034966920653160349669

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
017246562
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653160386318MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-14
00653160386271MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
00653160386288MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
00653160381986MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
00653160381993MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
00653160381801MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-10-28
00653160366570MEDLINEMEDLINE INDUSTRIES, INC.OFD2023-09-28
00653160351828MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
00653160351927MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
00653160350708MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
00653160350722MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
10653160349471CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-12-31
10653160349617CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-12-31
10653160349907CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-12-31
10653160349556MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-23
10653160349570MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-23
10653160349679MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-23
00653160349405MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
00653160349481CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-12-16
10653160349419MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349495MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349501MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349518MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349525MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349532MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160349563MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
00653160348743MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-11-05
00653160348385MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-10-01
20193489111139MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
20193489111146MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18