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New Image

FDA UDI

Class I (US FDA UDI)

by Hollister Incorporated

Identity

Trade Name
New Image FDA UDI
Generic Name
Urostomy bag/support kit FDA UDI
Device Name
Colostomy/Ileostomy Kit, CeraPlus FDA UDI
Model / Reference
19804 FDA UDI
Description
Colostomy/Ileostomy Kit, CeraPlus FDA UDI

Identifiers

Catalog Number
19804 FDA UDI
Primary DI / UDI-DI
00610075062546 FDA UDI
FDA Product Code
PQE FDA UDI
GMDN Term
Urostomy bag/support kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 70 Millimeter FDA UDI
Lumen/Inner Diameter — 57 Millimeter FDA UDI

Category: Urostomy bag/support kit

New Image by Hollister Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urostomy bag/support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hollister Incorporated

Sources (1)

  • FDA UDI d2303109-d2a2-4f65-bdc7-213d24f869e7 36 fields · synced Jun 9, 2026