Brava

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Brava FDA UDI
Generic Name: Peristomal/periwound dressing FDA UDI
Device Name: Brava Protective Seal. Feel Secure. Ostomy Care. Thickness 4.2 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in. FDA UDI
Model / Reference: 12046 FDA UDI
Description: Brava Protective Seal. Feel Secure. Ostomy Care. Thickness 4.2 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in. FDA UDI

Identifiers

Catalog Number: 12046 FDA UDI
Primary DI / UDI-DI: 05708932715737 FDA UDI
FDA Product Code: EXB FDA UDI
GMDN Term: Peristomal/periwound dressing 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 18 Millimeter FDA UDI
Outer Diameter — 57 Millimeter FDA UDI

Category: Peristomal/periwound dressing

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Coloplast A/S

Sources (1)

FDA UDI a52b83d6-1507-463a-9662-2cc5cdc0b1e0 37 fields · synced May 30, 2026