FDA.reportPublic FDA data

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Primary DI
00610075029891
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
11503
Catalog number
11503
Device description
2-Piece Ostomy Skin Barrier, Convex, CeraPlus
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
20610075029895PackageGS124In Commercial Distribution
00610075029891PrimaryGS10
00610075073603Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007502989520610075029895
00610075029891006100750298916100750298910610075029891
00610075073603006100750736036100750736030610075073603

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, convexA non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter22Millimeter
Lumen/Inner Diameter44Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075031849Hollister318431842022-12-01
00610075031863Hollister318631862022-12-01
00610075077601Adapt776077602022-12-01
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
00610075040070InstaFlo330162016-09-21
00610075052332Apogee HC908102016-09-21
00610075052349Apogee HC910062016-09-21
00610075052356Apogee HC910102016-09-21
00610075052363Apogee HC912062016-09-21
00610075052370Apogee HC912162016-09-21
00610075052387Apogee HC914062016-09-21
00610075052394Apogee HC914162016-09-21
00610075052400Apogee HC916162016-09-21
00610075052417Apogee HC918162016-09-21
00610075052424Apogee HC912262016-09-21
00610075052431Apogee HC914262016-09-21
00610075052448Apogee HC916262016-09-21

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
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01