Catalog Number

2255

Brand Name

Non-Sterile Probe Cover Kit

Version/Model Number

2255

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)

-

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

194ebd3e-c378-4927-b610-a8d76d34b3d8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10841912104175

Quantity per Package

50

Contains DI Package

00841912104178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-