Catalog Number

-

Brand Name

Exact Medical

Version/Model Number

E5346

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101689,K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

da9c01d3-670a-45ae-b3c6-4035b1a8982f

Public Version Date

June 18, 2021

Public Version Number

1

DI Record Publish Date

June 10, 2021

Package DI Number

00850031271456

Quantity per Package

40

Contains DI Package

00850031271449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case