Catalog Number

1109-XS

Brand Name

De Mayo Ankle Distractor™

Version/Model Number

1109-XS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

76dde1d9-8e2f-4dfb-82a9-778d6d9fd6ce

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-