Catalog Number

2023

Brand Name

PullUp Sterile Single-Use Surgical Probe Cover

Version/Model Number

2023

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

17cd1f40-a60e-49d7-90f0-dde3c79d3841

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Package DI Number

10841912106872

Quantity per Package

12

Contains DI Package

00841912106875

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-