FDA.reportPublic FDA data

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Primary DI
00610075029846
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
11203
Catalog number
11203
Device description
2-Piece Ostomy Skin Barrier, 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
20610075029840PackageGS136In Commercial Distribution
00610075029846PrimaryGS10
00610075082469Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007502984020610075029840
00610075029846006100750298466100750298460610075029846
00610075082469006100750824696100750824690610075082469

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, flatA non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the 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. It is typically self-applied by the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter44Millimeter
Lumen/Inner Diameter57Millimeter

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
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06
00610075094394VaPro Plus Pocket71102711022024-06-26
00610075094400VaPro Plus Pocket71122711222024-06-26
00610075094424VaPro Plus Pocket71142711422024-06-26
00610075094431VaPro Plus Pocket71084710842024-06-26
00610075094448VaPro Plus Pocket71104711042024-06-26
00610075094462VaPro Plus Pocket71124711242024-06-26
00610075099115CeraPlus89520895202026-05-29
00610075099122CeraPlus89530895302026-05-29
00610075099139CeraPlus89540895402026-05-29
00610075099146CeraPlus89601896012026-05-29
00610075099153CeraPlus89602896022026-05-29
00610075099160CeraPlus89603896032026-05-29
00610075093427Hollister934293422022-12-01
00610075093434Hollister934393432022-12-01
00610075097807Hollister978097802016-09-21
00610075097814Hollister978197812022-12-01
00610075097821Hollister978297822016-09-21

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
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
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01