Catalog Number

-

Brand Name

R-100 STERILE EQUIPEMENT COVER

Version/Model Number

PBKBG

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052395,K052395,K052395

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

ccb8745f-1361-4c94-b5db-e4294a11f911

Public Version Date

February 28, 2022

Public Version Number

6

DI Record Publish Date

September 08, 2016

Package DI Number

20845225012704

Quantity per Package

80

Contains DI Package

10845225012707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box