Catalog Number

-

Brand Name

FlexGuard Fiber with Sheath Calculase compatible

Version/Model Number

27750300U1CFS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 28, 2017

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

133a3c69-aa65-4a47-b7b6-85676a7efb02

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

July 28, 2016

Package DI Number

B14527750300U1C3FS1

Quantity per Package

3

Contains DI Package

B14527750300U1CFS0

Package Discontinue Date

March 28, 2017

Package Status

Not in Commercial Distribution

Package Type

box