VOCOM IMPLANT 3MM DISPLACEMENT DENSE HYDROXYLAPATITE - Provide an implant and securing shim to medialize - Gyrus Acmi, Inc.

Duns Number:007198742

Device Description: Provide an implant and securing shim to medialize the paralyzed vocal cord

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More Product Details

Catalog Number

-

Brand Name

VOCOM IMPLANT 3MM DISPLACEMENT DENSE HYDROXYLAPATITE

Version/Model Number

143000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K974311

Product Code Details

Product Code

KHJ

Product Code Name

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Device Record Status

Public Device Record Key

31fc322e-0276-4aca-88aa-0699ff1bb62e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4