MaxiFlex Holmium Laser Fiber - 365 micron Holmium Laser Fiber with SMA 905 - MAXIFLEX, LLC

Duns Number:198887072

Device Description: 365 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.

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More Product Details

Catalog Number

-

Brand Name

MaxiFlex Holmium Laser Fiber

Version/Model Number

MF 400BH D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K013300

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

1cf087b3-7b33-464c-a7f2-c27f6f4a1506

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXIFLEX, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 73