mytaMed - Med-Cam Endocoupler, 28mm - Mytamed, Inc.

Duns Number:015903922

Device Description: Med-Cam Endocoupler, 28mm

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More Product Details

Catalog Number

mV-8003

Brand Name

mytaMed

Version/Model Number

mV-8003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

FWL

Product Code Name

Camera, Cine, Endoscopic, Without Audio

Device Record Status

Public Device Record Key

0673df89-6c6d-48ca-873a-01e0e820e733

Public Version Date

March 19, 2021

Public Version Number

3

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYTAMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 861
2 A medical device with a moderate to high risk that requires special controls. 21