FDA.reportPublic FDA data

New Image

Primary DI
10610075062550
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
19902
Catalog number
19902
Device description
Urostomy Kit, CeraPlus
Published
2022-12-01
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
PQEOstomy care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQEOstomy Care KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075062550PackageGS112In Commercial Distribution
00610075062553PrimaryGS10
20610075062557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007506255010610075062550
00610075062553006100750625536100750625530610075062553
2061007506255720610075062557

GMDN Terms#

Term, Definition table
TermDefinition
Urostomy bag/support kitA collection of devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes not only the urostomy bag and base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter32Millimeter
Lumen/Inner Diameter44Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00610075093427Hollister934293422022-12-01
00610075093434Hollister934393432022-12-01
00610075097807Hollister978097802016-09-21
00610075097814Hollister978197812022-12-01
00610075097821Hollister978297822016-09-21
00610075097142Adapt780578052026-03-13
00610075097159Adapt780678062026-03-13
00610075097166Adapt781578152026-03-13
10610075097149Adapt780578052026-03-13
10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075198617New Image19353193532022-12-01
00610075071630Karaya 5716371632022-12-01
00610075085101Premier851085102022-12-01
00610075085132Premier851385132022-12-01
00610075085286Premier852885282022-12-01
00610075085927Premier859285922022-12-01
00610075173341Premier858485842022-12-01
00610075173365Premier85811858112022-12-01
00610075852116Premier85211852112022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075099443CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099450CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099474CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099481CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099498CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099504CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099511CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099528CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099603CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099610CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099627CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099440CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099457CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099471CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099488CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099495CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099501CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099518CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099525CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099600CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099617CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099624CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075098514New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098521New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098538New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098545New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098569New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098576New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075095735HollisterHOLLISTER INCORPORATEDPQE2024-10-01
00610075095742HollisterHOLLISTER INCORPORATEDPQE2024-10-01