AccessGUDID - DEVICE: SenSura Mio Convex (05701780341660)

GUDID

Device Identifier (DI) Information

Brand Name: SenSura Mio Convex
Version or Model: 16885
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16885
Company Name: Coloplast A/S

Primary DI Number: 05701780341660
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: No description.

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?
48158	Intestinal ostomy base plate, convex	A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate 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. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. 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
Special Storage Condition, Specify: This way up. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Base Plate Max Cut Size - mm 30
Lumen/Inner Diameter: 50 Millimeter
Device Size Text, specify: Base Plate Precut Start Hole Size - in 1 1/8
Device Size Text, specify: Base Plate Precut Start Hole Size - mm 28
Device Size Text, specify: Base Plate Max Cut Size - in 1 1/8
Device Size Text, specify: Base Plate Type Convex Soft
Device Size Text, specify: Coupling Size Diameter - in 1 15/16

Device Record Status

Public Device Record Key: ea59b6c0-5def-43a0-83fc-14c6918543dc
Public Version Date: April 29, 2024
Public Version Number: 1
DI Record Publish Date: April 19, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05701780341677	28	05701780341660		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: 05701780341684 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)533-0464
Email: healthcarecs@coloplast.com

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