Catalog Number

E105270

Brand Name

Exact Medical Medical Inc.

Version/Model Number

E105270

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

-

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

e5c10516-7ec3-4b6b-a1dc-c65c53999562

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

00850015378126

Quantity per Package

28

Contains DI Package

00850015378119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case