da Vinci Xi - VISION SIDE SYSTEM, RECONDITIONED - INTUITIVE SURGICAL, INC.

Duns Number:938647021

Device Description: VISION SIDE SYSTEM, RECONDITIONED

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More Product Details

Catalog Number

-

Brand Name

da Vinci Xi

Version/Model Number

380721

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

d58316ad-f242-474e-a222-7576a9a0145d

Public Version Date

March 02, 2020

Public Version Number

10

DI Record Publish Date

May 11, 2018

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