FLPL/WR MALL PSTN .8MM X 1MM X 6.75MM - Gyrus Acmi, Inc.

Duns Number:007198742

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

FLPL/WR MALL PSTN .8MM X 1MM X 6.75MM

Version/Model Number

70921877

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2017

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

K760435

Product Code Details

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Device Record Status

Public Device Record Key

5720d04f-3255-43a5-845b-eb3b9b95db19

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

October 06, 2016

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