FullFire® Select Diffusing Tip Laser Probe - 2.2mm Diffusing Tip Laser Probe - MONTERIS MEDICAL INC

Duns Number:021415875

Device Description: 2.2mm Diffusing Tip Laser Probe

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More Product Details

Catalog Number

FFS002-01

Brand Name

FullFire® Select Diffusing Tip Laser Probe

Version/Model Number

20624-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 2017

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

K143457

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

4d104ffd-9307-4a8a-9c0c-fdacae5073d1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONTERIS MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 111