Catalog Number

2016

Brand Name

PullUp Small Form Fitted Probe Cover Kit

Version/Model Number

2016

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"

-

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

61ad6234-fa43-430f-8225-268a01239d15

Public Version Date

May 18, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2018

Package DI Number

10841912105585

Quantity per Package

10

Contains DI Package

00841912105588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-