FDA.reportPublic FDA data

Coloplast

Primary DI
00762123001493
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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.

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
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