Catalog Number

2002EUR

Brand Name

PullUp Surgical Probe Cover Kit

Version/Model Number

2002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 14, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970889,K970893,K970889,K970893

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

7d4f9afb-5884-4f5c-9b3b-3708d922866e

Public Version Date

May 17, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

10841912100092

Quantity per Package

10

Contains DI Package

00841912100095

Package Discontinue Date

February 14, 2020

Package Status

Not in Commercial Distribution

Package Type

-