Catalog Number

EZTS01

Brand Name

ManaMed

Version/Model Number

ManaEZ Tendon Strap Universal

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IQI

Product Code Name

Orthosis, Limb Brace

Public Device Record Key

2b39e307-d4ff-4d47-a4ae-315cd18de7b9

Public Version Date

June 28, 2022

Public Version Number

1

DI Record Publish Date

June 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-