Halyard - Mounting Bracket for EZstim* III - Avanos Medical, Inc.

Duns Number:079375431

Device Description: Mounting Bracket for EZstim* III

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More Product Details

Catalog Number

MB500

Brand Name

Halyard

Version/Model Number

44735

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162048

Product Code Details

Product Code

KOI

Product Code Name

STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Device Record Status

Public Device Record Key

ea612115-84f0-49bb-b984-f11bf6f4297b

Public Version Date

November 16, 2018

Public Version Number

5

DI Record Publish Date

January 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221