StrykeCam - For Visum LED - STRYKER COMMUNICATIONS INC.

Duns Number:078807493

Device Description: For Visum LED

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More Product Details

Catalog Number

P45000

Brand Name

StrykeCam

Version/Model Number

P45000

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)

-

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

KQM

Product Code Name

CAMERA, SURGICAL AND ACCESSORIES

Device Record Status

Public Device Record Key

40af2939-dd08-42ec-b447-d9a34823edfc

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 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