BMI - Knee Corrective Orthosis, size Petite-Left - Blake Manufacturing, Inc.

Duns Number:103449711

Device Description: Knee Corrective Orthosis, size Petite-Left

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More Product Details

Catalog Number

-

Brand Name

BMI

Version/Model Number

KCO-PL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ITQ

Product Code Name

Joint, Knee, External Brace

Device Record Status

Public Device Record Key

d1d27cdb-756c-439b-8ae8-ddbca4b39162

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

December 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLAKE MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 325