SenSura Click - SenSura Click / SenSura Click ostomy baseplate - Coloplast A/S

Duns Number:305524696

Device Description: SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy baseplate. SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy baseplate. With belt ears. Coupling Size Diameter 50 mm, Coupling Size Diameter 2 in, Base Plate Precut Start Hole Size 35 mm, Base Plate Max Cut Size 45 mm, Baseplate Max Cut Size 1 3/4 in, Baseplate Precut Start Hole Size 1 3/8 in, Base Plate Type Flat.

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More Product Details

Catalog Number

10023

Brand Name

SenSura Click

Version/Model Number

10023

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EXB

Product Code Name

COLLECTOR, OSTOMY

Device Record Status

Public Device Record Key

ad4f9a1d-b95e-4ebe-9409-15b46395de53

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Additional Identifiers

Package DI Number

00762123054024

Quantity per Package

14

Contains DI Package

00762123054017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"COLOPLAST A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 899
3 A medical device with high risk that requires premarket approval 72
U Unclassified 7