MD Orthopaedics - Ankle foot orthosis, prefabricated (pair), to be - MD ORTHOPAEDICS, INC.

Duns Number:146220269

Device Description: Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2AFO Ankle foot orthosis, prefabricated (pair), to be attached to abduction brace, L1930 x 2AFO SIZE 9 PAIR CUSTOM COLOR

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More Product Details

Catalog Number

-

Brand Name

MD Orthopaedics

Version/Model Number

AFO-9-PR-COLORS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KNP

Product Code Name

Orthosis, Corrective Shoe

Device Record Status

Public Device Record Key

e8691b6c-9ac9-46a0-a128-07cbd5ffe061

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MD ORTHOPAEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 356