FDA.reportPublic FDA data

Fusion

Primary DI
10827002315225
Brand
Fusion
Company
COOK INCORPORATED
Model
G31522
Catalog number
FS-WL-O-S
Device description
Fusion Wire Guide Locking Device
Published
2016-09-24
Public version status
Update
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
OCYEndoscopic guidewire, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002315225PackageGS110In Commercial Distribution
00827002315228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700231522510827002315225
00827002315228008270023152288270023152280827002315228

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979988682154Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682161Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682178Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
06979988682185Routix™ Disposable Urologic GuidewireShenzhen HugeMed Medical Technical Development Co., Ltd.OCY2026-09-25
08809909421532GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421549GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421556GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421563GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421570GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421587GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421594GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421600GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
04953170465055VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465062VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465079VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465086VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465093VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465109VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465116VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465123VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465130VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465147VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465154VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465161VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465178VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465185VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465192VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465208VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767774SopranoColoplast A/SOCY2025-03-26
03600040926611ColoplastColoplast A/SOCY2024-04-19