NA - C-Mount Endoscope, Mitek Lock 30 degree x 3.5 mm - Medos International Sàrl

Duns Number:482661753

Device Description: C-Mount Endoscope, Mitek Lock 30 degree x 3.5 mm x 205 mm

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More Product Details

Catalog Number

242271

Brand Name

NA

Version/Model Number

242271

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K080560,K981751

Product Code Details

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Device Record Status

Public Device Record Key

ad218056-d2f2-462a-a68d-32c4b43c89fb

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

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