None - Swivel Connector - INTUITIVE SURGICAL, INC.

Duns Number:938647021

Device Description: Swivel Connector

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More Product Details

Catalog Number

-

Brand Name

None

Version/Model Number

490108

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2020

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

EOQ

Product Code Name

Bronchoscope (flexible or rigid)

Device Record Status

Public Device Record Key

9f9c1c6c-ea81-4a2c-bb8d-9abdc99d80cd

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

March 21, 2019

Additional Identifiers

Package DI Number

10886874116200

Quantity per Package

5

Contains DI Package

00886874116203

Package Discontinue Date

August 26, 2020

Package Status

Not 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