NA - Medium-Duty Dual Yoke - STRYKER COMMUNICATIONS INC.

Duns Number:078807493

Device Description: Medium-Duty Dual Yoke

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More Product Details

Catalog Number

0682-400-600

Brand Name

NA

Version/Model Number

0682400600

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

-

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

FQO

Product Code Name

TABLE, OPERATING-ROOM, AC-POWERED

Device Record Status

Public Device Record Key

1693cadb-8857-497a-998e-1a88873e9372

Public Version Date

August 06, 2020

Public Version Number

1

DI Record Publish Date

July 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER COMMUNICATIONS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 9