MaxYs 4mm Adapter - MaxYs 4mm Adapter - Cynosure, Inc.

Duns Number:780318028

Device Description: MaxYs 4mm Adapter

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More Product Details

Catalog Number

-

Brand Name

MaxYs 4mm Adapter

Version/Model Number

2520-0045

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Device Record Status

Public Device Record Key

bb779531-1ab4-46a6-bb40-6ada34f81f7c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10841494103573

Quantity per Package

5

Contains DI Package

00841494103576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CYNOSURE, 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. 154