N/A - MyoSure Tissue Removal Device - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: MyoSure Tissue Removal Device

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More Product Details

Catalog Number

10-401

Brand Name

N/A

Version/Model Number

N/A

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

Yes

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

K201756,K201756,K201756

Product Code Details

Product Code

HIH

Product Code Name

HYSTEROSCOPE (AND ACCESSORIES)

Device Record Status

Public Device Record Key

52bb794f-10dd-436f-84f6-301f2f96b8aa

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Additional Identifiers

Package DI Number

37613327507103

Quantity per Package

3

Contains DI Package

07613327507102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER SUSTAINABILITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 304
2 A medical device with a moderate to high risk that requires special controls. 1702
U Unclassified 12