AccessGUDID - DEVICE: Brava (05708932715737)

GUDID

Device Identifier (DI) Information

Brand Name: Brava
Version or Model: 12046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12046
Company Name: Coloplast A/S

Primary DI Number: 05708932715737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 18 Millimeter
Outer Diameter: 57 Millimeter
Device Size Text, specify: Diameter Inner - in 3/4
Device Size Text, specify: Diameter Outer - in 2 1/4
Device Size Text, specify: Thickness - mm 4.2

Device Record Status

Public Device Record Key: a52b83d6-1507-463a-9662-2cc5cdc0b1e0
Public Version Date: April 18, 2022
Public Version Number: 1
DI Record Publish Date: April 08, 2022