Catalog Number

2696

Brand Name

Sterile Single-Use Surgical Probe Cover Kit

Version/Model Number

2696

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

0f32cc9f-cfda-4f9e-9cb9-669739351f52

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Package DI Number

10841912107091

Quantity per Package

24

Contains DI Package

00841912107094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-