MF-272/300-SD-Flexx - Surgical Laser Fiber , 272/300/450, silicone, - MED -FIBERS INC.

Duns Number:058701385

Device Description: Surgical Laser Fiber , 272/300/450, silicone, blue tefzel, NA 0.22, Superdry Connector® SM Surgical Laser Fiber , 272/300/450, silicone, blue tefzel, NA 0.22, Superdry Connector® SMA 905, Flexx Trak™ Ball Tip, single use, extension sleeve, EO sterile, label

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More Product Details

Catalog Number

-

Brand Name

MF-272/300-SD-Flexx

Version/Model Number

MF-272/300-SD-Flexx

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

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

K124003

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

24f54623-116f-4532-b6df-0111ade69cb4

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED -FIBERS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 63