Catalog Number

SA-1103020

Brand Name

FiberLase™ Endoscope Protection Sheath

Version/Model Number

FiberLase™ Endoscope Protection Sheath

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

3a1135d7-dc5e-44b0-90eb-185b4604a8a2

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Package DI Number

17290109146611

Quantity per Package

5

Contains DI Package

07290109146614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-