Catalog Number

X0008236

Brand Name

TranEnterix

Version/Model Number

X0008236

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

3412e2ef-05f6-48e3-afc0-1524d1332910

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

17466532979045

Quantity per Package

20

Contains DI Package

07466532979048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box