Catalog Number

23024

Brand Name

Medrobotics

Version/Model Number

23024

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

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

870e443a-d893-496a-8e3c-257e31dc52b4

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 24, 2018

Package DI Number

00852205007991

Quantity per Package

10

Contains DI Package

00852205007984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case