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

K001802,K001802

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

1a424d2a-c76e-4890-8b02-4981e74598f0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 20, 2017

Package DI Number

50748426036238

Quantity per Package

25

Contains DI Package

00748426036233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-