AccessGUDID - DEVICE: SenSura Click (05708932408691)

GUDID

Device Identifier (DI) Information

Brand Name: SenSura Click
Version or Model: 10045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10045
Company Name: Coloplast A/S

Primary DI Number: 05708932408691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: SenSura Click / SenSura Click Click Xpro ostomy baseplate / Coloplast / Coloplast Click Xpro ostomy baseplate / SenSura Click SenSura Click Xpro ostomy baseplate / Coloplast SenSura Click Xpro ostomy baseplate / SenSura Product name: 2-piece Ostomy bag / SenSura Click Xpro ostomy baseplate. With belt ears. Not for individual sale. Registered trademark phrase for Mexico. Maxi. Coupling Size Diameter 70 mm, Coupling Size Diameter 2 3/4 in, Base Plate Precut Start Hole Size 10 mm, Base Plate Max Cut Size 65 mm, Baseplate Max Cut Size 2 9/16 in, Baseplate Precut Start Hole Size 3/8 in, Base Plate Type Flat.

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?
48159	Intestinal ostomy base plate, flat	A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. This is a single-use device.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Base Plate Max Cut Size - mm 65
Device Size Text, specify: Coupling Size Diameter - in 2 3/4
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 10
Device Size Text, specify: Baseplate Precut Start Hole Size - in 3/8
Device Size Text, specify: Baseplate Max Cut Size - in 2 9/16
Lumen/Inner Diameter: 70 Millimeter

Device Record Status

Public Device Record Key: 29d6453e-8114-4f36-b6ec-d15c5cf9033d
Public Version Date: May 16, 2022
Public Version Number: 1
DI Record Publish Date: May 06, 2022