FDA.reportPublic FDA data

Centurion

Primary DI
10653160249559
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
GW3560I
Published
2016-09-13
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
00653160249552PackageGS110In Commercial Distribution
20653160249556PackageGS110In Commercial Distribution
30653160249553PackageGS110In Commercial Distribution
10653160249559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160249552006531602495526531602495520653160249552
2065316024955620653160249556
3065316024955330653160249553
1065316024955910653160249559

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
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
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

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
10193489111170MEDLINEMEDLINE 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