DEVICE: Brava (05708932702621)

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Device Record History
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Device Identifier (DI) Information
Brava
32155
In Commercial Distribution
32155
Coloplast A/S
05708932702621
GS1

1
305524696 *Terms of Use
Brava® Protective Sheet. Ostomy Care. 6 x 6 in
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Device Characteristics
MR Safe
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
10284 Pressure bandage, non-latex, single-use
A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, wound, occlusive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Width: 6 Inch
Length: 6 Inch
Length: 15 Centimeter
Width: 15 Centimeter
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Device Record Status
7e88b713-0a98-4482-a526-6911d718620a
April 18, 2022
1
April 08, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05708932501477 24 05708932501460 In Commercial Distribution Shipper Box
05708932501460 5 05708932702621 In Commercial Distribution Retail Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
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