Catalog Number

-

Brand Name

MediClear™ PreOp

Version/Model Number

7001012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K163556,K163556,K163556

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

629f8319-f256-42cd-a120-cc52da0b9e67

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

April 30, 2018

Package DI Number

10825439012809

Quantity per Package

4

Contains DI Package

00825439012796

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper