DEVICE: Brava (05708932715720)
Device Identifier (DI) Information
Brava
12036
In Commercial Distribution
12036
Coloplast A/S
12036
In Commercial Distribution
12036
Coloplast A/S
Brava Protective Seal.
Feel Secure. Ostomy Care. Thickness 2.5 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in.
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? |
---|---|---|---|---|
46207 | Peristomal/periwound dressing |
A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EXB | COLLECTOR, OSTOMY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Thickness - mm 2.5 |
Lumen/Inner Diameter: 18 Millimeter |
Device Size Text, specify: Diameter Inner - in 3/4 |
Outer Diameter: 57 Millimeter |
Device Size Text, specify: Diameter Outer - in 2 1/4 |
Device Record Status
761f1bc0-ef32-460b-be4e-45a78a3e7a27
April 18, 2022
1
April 08, 2022
April 18, 2022
1
April 08, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05708932409452 | 10 | 05708932715720 | In Commercial Distribution | Retail Box | |
05708932409438 | 50 | 05708932409452 | In Commercial Distribution | Shipper Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com