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

-

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

88aaff1c-2cde-49d0-a0ca-ee5fea94dcf3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 29, 2016

Package DI Number

50748426040884

Quantity per Package

5

Contains DI Package

00748426112548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-