Laser Surgery Fibers and Probes - Otology probe curved tip 20° universal centering - A.R.C. Laser GmbH

Duns Number:314885641

Device Description: Otology probe curved tip 20° universal centering

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More Product Details

Catalog Number

LL28059s

Brand Name

Laser Surgery Fibers and Probes

Version/Model Number

LL28059s

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

K161403,K161403,K161403,K161403

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

cbac6d66-2e8a-45c8-8682-5c8f737ff534

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

October 28, 2016

Additional Identifiers

Package DI Number

04260155591921

Quantity per Package

30

Contains DI Package

04260155591518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"A.R.C. LASER GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5