Catalog Number

ACE07-15S EX

Brand Name

ACE Medical

Version/Model Number

ACE07-15S EX

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

K200387

Product Code

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

75d57c3a-2d64-4b8b-b7df-cac7505a9269

Public Version Date

September 20, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-