FDA.reportPublic FDA data

Clik-FIX

Primary DI
00850933007290
Brand
Clik-FIX
Company
STARBOARD MEDICAL, INC.
Model
FCS-1075
Catalog number
FCS-1075
Device description
Foley Catheter Securement device for 5-8 Fr.
Published
2019-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850933007297PackageGS150In Commercial Distribution
00850933007290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085093300729710850933007297
00850933007290008509330072908509330072900850933007290

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holder, sterileA sterile device designed to be attached to a patient's body to hold an indwelling urinary catheter (e.g., Foley, ureteral), or a tube attached to it, in place. It typically consists of a wrap placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook/loop closure, spring tensioner) without creating excessive pressure on it and permitting visual inspection of the site. This is a single-use device.

Regulatory Flags#

DUNS number
012983893
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850933007009Clik-FIXWCS-1061WCS-10612017-01-30
00850933007016Clik-FIXPCS-1011PCS-10112016-09-30
00850933007139Clik-FIXWCS-1003WCS-10032016-09-30
00850933007146Clik-FIXWCS-1051WCS-10512017-01-30
00850933007184Clik-FIXPCS-1012PCS-10122017-03-16
00850933007191Clik-FIXWCS-1052WCS-10522017-08-07
00850933007221Clik-FIXWCS-1006WCS-10062018-05-30
00866896000018Clik-FIXWCS-1000WCS-10002017-01-24
00850933007269Clik-FIXNPS-1006NPS-10062019-04-18
00850933007153Clik-FIXLLS-1021LLS-10212017-02-27
00850933007160Clik-FIXABS-1022ABS-10222017-03-14
00850933007252Clik-FIXLLS-1024LLS-10242018-10-10
10850933007204Clik-FIXLLSK-1024LLSK-10242019-03-08
20850933007201Clik-FIXLLSK-1024LLSK-10242019-03-08
10850933007242Clik-FIXPCK-1011PCK-10112019-03-08
10850933007006Clik-FIXWCS-1061WCS-10612017-01-30
10850933007013Clik-FIXPCS-1011PCS-10112016-09-30
10850933007136Clik-FIXWCS-1003WCS-10032016-09-30
10850933007143Clik-FIXWCS-1051WCS-10512017-01-30
10850933007181Clik-FIXPCS-1012PCS-10122017-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071054MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10192253071153MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10885380211256MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
00850067913009TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00850067913016TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479280687McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281189McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281202McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281226McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283522FlexGRIPBedalEYJ2025-12-03
05430004283782FlexGRIPBedalEYJ2025-12-03
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674284FlexGRIPBedalEYJ2025-12-01
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
00850058254333TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254364TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254371TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
50850058254376TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
20653160386367CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
10653160386360CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14