Catalog Number

2201COO

Brand Name

Non-Sterile Endocavity Probe Cover with Bands

Version/Model Number

2201

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

0e2a2b38-fff2-4409-a53f-ce9874943fcf

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-