MEDI - ACHIMED ACHILLES SUPP BLACK VI - MEDI MANUFACTURING, INC.

Duns Number:960754430

Device Description: ACHIMED ACHILLES SUPP BLACK VI

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More Product Details

Catalog Number

-

Brand Name

MEDI

Version/Model Number

K020516

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

Yes

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

ITW

Product Code Name

JOINT, ANKLE, EXTERNAL BRACE

Device Record Status

Public Device Record Key

eba53c36-81da-4221-a1ef-0a937a028da4

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2971
2 A medical device with a moderate to high risk that requires special controls. 9550