Catalog Number

-

Brand Name

ScopeGuardian™ Sheath only

Version/Model Number

10918

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"

-

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

K100194,K100194

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

87358253-41fb-47d9-b26f-7b172591078d

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

August 03, 2016

Package DI Number

B145109201

Quantity per Package

3

Contains DI Package

B145109180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box