Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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"

-

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

K910515,K910515

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

2ed7610d-8a0a-4d59-b8cb-002cc6458c98

Public Version Date

February 11, 2019

Public Version Number

4

DI Record Publish Date

March 10, 2017

Package DI Number

50748426095518

Quantity per Package

10

Contains DI Package

00748426095513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-