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Premium

FDA UDI

Class I (US FDA UDI)

by Hollister Incorporated

Identity

Trade Name
Premium FDA UDI
Generic Name
Intestinal ostomy base plate, flat FDA UDI
Device Name
Ostomy Skin Barrier FDA UDI
Model / Reference
7800 FDA UDI
Description
Ostomy Skin Barrier FDA UDI

Identifiers

Catalog Number
7800 FDA UDI
Primary DI / UDI-DI
00610075078004 FDA UDI
FDA Product Code
EXE FDA UDI
GMDN Term
Intestinal ostomy base plate, flat 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
Width — 10 Centimeter FDA UDI
Height — 10 Centimeter FDA UDI

Category: Intestinal ostomy base plate, flat

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

Similar devices

Also classified as Intestinal ostomy base plate, flat.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hollister Incorporated

Sources (1)

  • FDA UDI 8881f012-4d5e-4df3-ac49-f23bd58bef19 36 fields · synced Jun 9, 2026