NA - TMJ Endoscope, Autoclavable - STRYKER CORPORATION

Duns Number:187502109

Device Description: TMJ Endoscope, Autoclavable

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More Product Details

Catalog Number

502-142-010

Brand Name

NA

Version/Model Number

0502142010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2020

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

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

b7d66824-1781-4729-bd43-39a2ec829fb8

Public Version Date

February 05, 2020

Public Version Number

4

DI Record Publish Date

November 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60