mytaMed - Nasal Sinus Scissors, 130mm WL, Tube Shaft, Left - Mytamed, Inc.

Duns Number:015903922

Device Description: Nasal Sinus Scissors, 130mm WL, Tube Shaft, Left

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More Product Details

Catalog Number

7.27.42

Brand Name

mytaMed

Version/Model Number

7.27.42

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2018

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

KBD

Product Code Name

Scissors, Nasal

Device Record Status

Public Device Record Key

70e88050-e85e-4fd7-af1e-608407c37cef

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 19, 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