NA - Lock Wrench - STRYKER MEDTECH K.K.

Duns Number:690682147

Device Description: Lock Wrench

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More Product Details

Catalog Number

5450800040

Brand Name

NA

Version/Model Number

5450800040

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 14, 2017

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

-

Product Code Details

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

48b92216-9f94-45f9-9a6b-4be2b3a41b80

Public Version Date

July 05, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER MEDTECH K.K." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
U Unclassified 8