Catalog Number

SA-20055430

Brand Name

OtoLase™ Straight Tip

Version/Model Number

OtoLase™ Straight Tip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

2f481a5e-6a37-4a38-892e-96abf1c79e2e

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 04, 2022

Package DI Number

17290109146796

Quantity per Package

12

Contains DI Package

07290109146799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-