NA - HD Coupler, C-Mount 20mm - Medos International Sàrl

Duns Number:482661753

Device Description: HD Coupler, C-Mount 20mm

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More Product Details

Catalog Number

242316

Brand Name

NA

Version/Model Number

242316

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FEM

Product Code Name

ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

Device Record Status

Public Device Record Key

c7367278-5ce2-4de4-9be4-1a5fda38c67e

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

April 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20