Catalog Number

-

Brand Name

SmartScope 550 micron fiber, reusable

Version/Model Number

RE-550-DO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K022338,K022338

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

d9c8fa19-cfad-4ecc-80d5-002ae1cf2630

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

April 11, 2019

Package DI Number

B145117781

Quantity per Package

5

Contains DI Package

B145117760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX