Catalog Number

990.11.90

Brand Name

Medicon

Version/Model Number

990.11.90

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

-

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

FZO

Product Code Name

CHISEL, SURGICAL, MANUAL

Public Device Record Key

db9c3e4b-32aa-4616-85b3-1b6fd6564d2e

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-