FDA.reportPublic FDA data

Brava

Primary DI
05708932565721
Brand
Brava
Company
Coloplast A/S
Model
4247.0
Catalog number
4247.0
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

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
05708932565714PackageGS115In Commercial Distribution
05708932565721PackageGS112In Commercial Distribution
05708932135245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932565714057089325657145708932565714
05708932565721057089325657215708932565721
05708932135245057089321352455708932135245

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305524696
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
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14
00762123030196Conveen Security+21346213462022-03-11
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

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