None - None - INTUITIVE SURGICAL, INC.

Duns Number:938647021

Device Description: None

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More Product Details

Catalog Number

-

Brand Name

None

Version/Model Number

430075

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

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

NAY

Product Code Name

System, surgical, computer controlled instrument

Device Record Status

Public Device Record Key

6a7f167b-7f0d-4700-a580-073b303a0440

Public Version Date

March 19, 2021

Public Version Number

1

DI Record Publish Date

March 11, 2021

Additional Identifiers

Package DI Number

10886874119553

Quantity per Package

6

Contains DI Package

00886874119556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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