MICROTEK - VENODYNE BARIATRIC FOOT SLEEVE - Microtek Medical Inc.

Duns Number:106908437

Device Description: VENODYNE BARIATRIC FOOT SLEEVE

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More Product Details

Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K110358,K110358

Product Code Details

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Device Record Status

Public Device Record Key

1fa6e1c9-1a2f-4adb-878d-a73c127ebfd8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 17, 2017

Additional Identifiers

Package DI Number

50748426081849

Quantity per Package

5

Contains DI Package

00748426081844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MICROTEK MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 919