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Premier

FDA UDI

Class I (US FDA UDI)

by Hollister Incorporated

Identity

Trade Name
Premier FDA UDI
Generic Name
One-piece intestinal ostomy bag, open-ended FDA UDI
Device Name
1-Piece Drainable Ostomy Pouch, Soft, Convex, CeraPlus FDA UDI
Model / Reference
8195411 FDA UDI
Description
1-Piece Drainable Ostomy Pouch, Soft, Convex, CeraPlus FDA UDI

Identifiers

Catalog Number
8195411 FDA UDI
Primary DI / UDI-DI
00610075089277 FDA UDI
FDA Product Code
EXB FDA UDI
GMDN Term
One-piece intestinal ostomy bag, open-ended 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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 — 15 Millimeter FDA UDI
Lumen/Inner Diameter — 55 Millimeter FDA UDI

Category: One-piece intestinal ostomy bag, open-ended

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

Similar devices

Also classified as One-piece intestinal ostomy bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hollister Incorporated

Sources (1)

  • FDA UDI 9590ed19-81e1-4b7c-b28a-70ccce64fd15 36 fields · synced Jun 9, 2026