EndoWrist;daVinci Si - HARMONIC ACE - INTUITIVE SURGICAL, INC.

Duns Number:938647021

Device Description: HARMONIC ACE

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More Product Details

Catalog Number

-

Brand Name

EndoWrist;daVinci Si

Version/Model Number

420274

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

NAY

Product Code Name

System,surgical,computer controlled instrument

Device Record Status

Public Device Record Key

6f0100e4-5956-49ae-a7fb-e66f9ee4744a

Public Version Date

May 13, 2021

Public Version Number

8

DI Record Publish Date

July 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTUITIVE SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 376