00855950006547 - Surgical Laser Fiber 272/300/380/450 micron, - MED -FIBERS INC.

Duns Number:058701385

Device Description: Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 9 Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 905 HHz connector(TM), blue boot, single use, blue extension sleeve, Dome Tip, MF label

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More Product Details

Catalog Number

-

Brand Name

00855950006547

Version/Model Number

MF-272/300Series

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)

-

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

9722e0fa-3ad7-49fa-ae95-cccd2ed5b55b

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 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