Catalog Number

1021206

Brand Name

PullUp Probe Cover Kit

Version/Model Number

2295

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

K970893,K970893

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

2134e725-66e2-4e15-a07d-fcefd499008c

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

February 09, 2018

Package DI Number

10841912105363

Quantity per Package

24

Contains DI Package

00841912105366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-