ENDO-EAR - ENDO-EAR Suction, Long Curve, 20 Ga, Up - Mytamed, Inc.

Duns Number:015903922

Device Description: ENDO-EAR Suction, Long Curve, 20 Ga, Up

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More Product Details

Catalog Number

1.85.20

Brand Name

ENDO-EAR

Version/Model Number

1.85.20

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

JZF

Product Code Name

Tube, Ear Suction

Device Record Status

Public Device Record Key

0928b129-8566-46fd-b1d2-c49241cff259

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

January 25, 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