MFR-150/180-HHz - Surgical Laser Fiber 150/180/210/350 micron, hard - MED -FIBERS INC.

Duns Number:058701385

Device Description: Surgical Laser Fiber 150/180/210/350 micron, hard clad, blue tefzel, NA 0.22, SMA 905 HHz Surgical Laser Fiber 150/180/210/350 micron, hard clad, blue tefzel, NA 0.22, SMA 905 HHz connector(TM), boot, reusable, silver extension sleeve, Flat Tip, MF label

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More Product Details

Catalog Number

-

Brand Name

MFR-150/180-HHz

Version/Model Number

MFR-150/180-HHz

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

K124003

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

fd9e00df-072a-4462-8632-0cb540052d59

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 2021

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