PhotonBlade with Adaptive Smoke Evacuation - The PhotonBlade with Adaptive Smoke Evacuation is - STRYKER CORPORATION

Duns Number:196548481

Device Description: The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled with illum The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

PB2SE

Brand Name

PhotonBlade with Adaptive Smoke Evacuation

Version/Model Number

PB2SE

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"

Yes

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

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

b9f547f8-3859-4b21-aa6b-f56b6d8ea3e5

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

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