DE LA CRUZ PISTON 06MM DIA 450MM LENGTH STAINLESS STEELFLUOROPLASTIC - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

DE LA CRUZ PISTON 06MM DIA 450MM LENGTH STAINLESS STEELFLUOROPLASTIC

Version/Model Number

70140729

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K760433

Product Code Details

Product Code

ETA

Product Code Name

Replacement, Ossicular Prosthesis, Total

Device Record Status

Public Device Record Key

9a97bfc8-e842-4b20-9471-448fb51668af

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