FDA.reportPublic FDA data

Coloplast

Primary DI
05708932702942
Brand
Coloplast
Company
Coloplast A/S
Model
9500
Catalog number
9500
Device description
Coloplast Clamp . For drainable ostomy bags.
Published
2022-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123001493PackageGS120In Commercial Distribution
00762123007259PackageGS110In Commercial Distribution
05708932702942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123001493007621230014937621230014930762123001493
00762123007259007621230072597621230072590762123007259
05708932702942057089327029425708932702942

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy bag closure deviceA device intended to facilitate the emptying and/or reclosure of an open-ended ostomy bag. This is a reusable device.

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
05701780385411SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385442SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385473SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385503SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385541SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385572SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385602SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385633SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385664SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385701SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385732SenSura Mio ConvexColoplast A/SEXB2026-06-08
05701780385763SenSura Mio ConvexColoplast A/SEXB2026-06-08
09421905447225The Insides NeoTHE INSIDES COMPANY LIMITEDEXB2025-10-16
09421905447195The Insides NeoTHE INSIDES COMPANY LIMITEDEXB2023-05-26
10610075077158m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077172m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077325m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077332m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077349m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077356m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077363m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075114747New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029839New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029846New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029853New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029860New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029877New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029884New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029891New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01