HKO 16" KNEE W/ ROM HINGE XL - Bird & Cronin, LLC

Duns Number:045975349

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More Product Details

Catalog Number

-

Brand Name

HKO 16" KNEE W/ ROM HINGE XL

Version/Model Number

08146495

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)

-

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

5be3fbf4-4ae7-4893-9a3a-0a6b09faf6d5

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIRD & CRONIN, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2022