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Assura

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Assura FDA UDI
Generic Name
Multiple-piece intestinal ostomy bag, open-ended FDA UDI
Model / Reference
12577 FDA UDI

Identifiers

Catalog Number
12577 FDA UDI
Primary DI / UDI-DI
00762123018545 FDA UDI
FDA Product Code
EXB FDA UDI
GMDN Term
Multiple-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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 40 Millimeter FDA UDI

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

Assura by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 33161091-5add-4278-9eaa-4b684e80c863 35 fields · synced May 30, 2026