FDA.reportPublic FDA data

Brava

Primary DI
05708932135252
Brand
Brava
Company
Coloplast A/S
Model
4237
Catalog number
4237
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXNSUPPORT, HERNIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXNSupport, HerniaGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932565684PackageGS115In Commercial Distribution
05708932565691PackageGS18In Commercial Distribution
05708932135252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932565684057089325656845708932565684
05708932565691057089325656915708932565691
05708932135252057089321352525708932135252

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy bag pressure bandageA piece, strip, or band of material designed to apply pressure to stabilize an ostomy bag (receptacle that collects bodily waste through a stoma) to a patient's body. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05701780385411SenSura Mio Convex18541185412026-06-08
05701780385442SenSura Mio Convex18542185422026-06-08
05701780385473SenSura Mio Convex18543185432026-06-08
05701780385503SenSura Mio Convex18544185442026-06-08
05701780385541SenSura Mio Convex18545185452026-06-08
05701780385572SenSura Mio Convex18546185462026-06-08
05701780385602SenSura Mio Convex18547185472026-06-08
05701780385633SenSura Mio Convex18548185482026-06-08
05701780385664SenSura Mio Convex18549185492026-06-08
05701780385701SenSura Mio Convex18550185502026-06-08
05701780385732SenSura Mio Convex18551185512026-06-08
05701780385763SenSura Mio Convex18540185402026-06-08
05708932487047Peristeen29125291252016-09-20
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435025919709ORLIMANORLIMAN S.L.U.EXN2024-07-10
08435025922143ORLIMANORLIMAN S.L.U.EXN2024-07-10
08435025922150ORLIMANORLIMAN S.L.U.EXN2024-07-10
05391512282905HPH Corp.INDACO SRLEXN2024-04-04
05391512282912HPH Corp.INDACO SRLEXN2024-04-04
05391512282929HPH Corp.INDACO SRLEXN2024-04-04
05391512282936HPH Corp.INDACO SRLEXN2024-04-04
05391512282943HPH Corp.INDACO SRLEXN2024-04-04
05391512282950HPH Corp.INDACO SRLEXN2024-04-04
05391512282967HPH Corp.INDACO SRLEXN2024-04-04
05391512282974HPH Corp.INDACO SRLEXN2024-04-04
05391512282981HPH Corp.INDACO SRLEXN2024-04-04
05391512282998HPH Corp.INDACO SRLEXN2024-04-04
05391512283001HPH Corp.INDACO SRLEXN2024-04-04
05391512283018HPH Corp.INDACO SRLEXN2024-04-04
05391512283025HPH Corp.INDACO SRLEXN2024-04-04
05391512283032HPH Corp.INDACO SRLEXN2024-04-04
05391512283049HPH Corp.INDACO SRLEXN2024-04-04
05391512283056HPH Corp.INDACO SRLEXN2024-04-04
05391512283087HPH Corp.INDACO SRLEXN2024-04-04
05391512283094HPH Corp.INDACO SRLEXN2024-04-04
05391512283100HPH Corp.INDACO SRLEXN2024-04-04
05391512283117HPH Corp.INDACO SRLEXN2024-04-04
05391512283124HPH Corp.INDACO SRLEXN2024-04-04
05391512283131HPH Corp.INDACO SRLEXN2024-04-04
05391512283148HPH Corp.INDACO SRLEXN2024-04-04
05391512283155HPH Corp.INDACO SRLEXN2024-04-04
05391512283162HPH Corp.INDACO SRLEXN2024-04-04
05391512283179HPH Corp.INDACO SRLEXN2024-04-04
05391512283186HPH Corp.INDACO SRLEXN2024-04-04