8013141 - 600u Ball Tip Laser Fiber - LASER PERIPHERALS, LLC

Duns Number:177234754

Device Description: 600u Ball Tip Laser Fiber

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More Product Details

Catalog Number

8013141

Brand Name

8013141

Version/Model Number

8013141

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

-

Product Code Details

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Device Record Status

Public Device Record Key

8f3a15b9-392a-46ea-9cd1-e5314a9b8b0a

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LASER PERIPHERALS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 163