FDA.reportPublic FDA data

FlexGRIP

Primary DI
05430004283539
Brand
FlexGRIP
Company
Bedal
Model
FlexGRIP Foley 11-18 Fr
Catalog number
FOL1118-B
Device description
Sterilized - GTIN UDI without CE mark: applicable for lot 01
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
05430004283539PackageGS1400In Commercial Distribution
05430004283522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430004283539054300042835395430004283539
05430004283522054300042835225430004283522

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3211286902info@bedal.be

Regulatory Flags#

DUNS number
370066406
Device count
1
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430000258005FlexGRIPFlexGRIP Universal 5-11 FrUN511-CAP2026-04-30
05430000258753FlexGRIPFlexGRIP Universal 11-18 FrUN1118-CAP2026-04-30
05430004283492FlexGRIPFlexGRIP Universal 18-25 FrUN1825-CAP2026-04-30
05430004283928FlexGRIPFlexGRIP Neo. PICCPICCNEO-B2025-12-19
05430004283935FlexGRIPFlexGRIP Neo. PICCPICCNEO-B2025-12-19
05430000258647Bedal FlexGRIP CVC 4.5-9 FrCVC459HS2025-12-03
05430003674000FlexGRIPFlexGRIP Universal 5-11 FrFLEXS-10; FLEXS-502025-12-03
05430003674055FlexGRIPFlexGRIP Universal 11-18 FrUN1118; FLEX-M-10; FLEX-M-502025-12-03
05430003674222Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36HS2025-12-03
05430003674253Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36002025-12-03
05430004283522FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283782FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03
05430004283805Bedal FlexGRIP EPI/PNB 20-16GEP02-B2025-12-03
05430000258494FlexGRIPFlexGRIP Universal 11-18 FrUN11182025-12-03
05430000258654Bedal FlexGRIP CVC 4.5-9 FrCVC459HS2025-12-03
05430003674017FlexGRIPFlexGRIP Universal 5-11 FrFLEXS-10; FLEXS-502025-12-03
05430003674062FlexGRIPFlexGRIP Universal 11-18 FrUN1118; FLEX-M-10; FLEX-M-502025-12-03
05430003674239Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36HS2025-12-03
05430003674260Bedal FlexGRIP Jr. CVC 3-6 FrCVCJR36002025-12-03
05430004283799FlexGRIPFlexGRIP Foley 11-18 FrFOL1118-B2025-12-03

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
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
00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.EYJ2024-12-16