EndoWrist - CARDIOVAC TUBING - INTUITIVE SURGICAL, INC.

Duns Number:938647021

Device Description: CARDIOVAC TUBING

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More Product Details

Catalog Number

-

Brand Name

EndoWrist

Version/Model Number

420186

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

f8d15c59-1947-419f-9d27-cb45c73a67e9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

30886874115238

Quantity per Package

5

Contains DI Package

10886874115234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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