FDA.reportPublic FDA data

CeraPlus

Primary DI
00610075097180
Brand
CeraPlus
Company
HOLLISTER INCORPORATED
Model
8815
Catalog number
8815
Device description
Ostomy Barrier Ring
Published
2026-01-15
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
EXEProtector, ostomy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075097187PackageGS136In Commercial Distribution
00610075097180PrimaryGS10
00610075097302Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007509718710610075097187
00610075097180006100750971806100750971800610075097180
00610075097302006100750973026100750973020610075097302

GMDN Terms#

Term, Definition table
TermDefinition
Peristomal/periwound dressingA non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter48Millimeter
Width2.3Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
10
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
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15
00610075096541VaPro Plus Pocket Kit79089K79089K2025-01-24
00610075096602VaPro Plus Pocket Kit79109K79109K2025-01-24
00610075096619VaPro Plus Pocket Kit79129K79129K2025-01-24
00610075096626VaPro Plus Pocket Kit79149K79149K2025-01-24
00610075096633VaPro Plus Pocket Kit79169K79169K2025-01-24
00610075102082Advance Plus96064IC96064IC2016-09-21
00610075102099Advance Plus96084IC96084IC2016-09-21
00610075102105Advance Plus96104IC96104IC2016-09-21
00610075102112Advance Plus96124IC96124IC2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441545ViveVIVE HEALTH LLCEXE2026-08-03
00810226441552ViveVIVE HEALTH LLCEXE2026-08-03
00610075099115CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099122CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099139CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099146CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099153CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099160CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
15056276805513EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819060EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819084EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097210AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097227AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109333EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109340EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455118250EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455139170EakinT.G. EAKIN LIMITEDEXE2023-05-16
00610075092796CeraPlusHOLLISTER INCORPORATEDEXE2023-05-12
16937359412653SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.EXE2022-12-21
00610075053063AdaptHOLLISTER INCORPORATEDEXE2022-12-01
00610075059713Adapt CeraRingHOLLISTER INCORPORATEDEXE2022-12-01