OrthAlign Plus - BKS - Balance Interchangeable Drill Plate - Sizes - ORTHALIGN, INC.

Duns Number:023266163

Device Description: BKS - Balance Interchangeable Drill Plate - Sizes 6-7

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More Product Details

Catalog Number

402162

Brand Name

OrthAlign Plus

Version/Model Number

402162

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)

Yes

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

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Device Record Status

Public Device Record Key

bf6e76a6-1091-4e75-8149-53b034f389cd

Public Version Date

March 21, 2022

Public Version Number

2

DI Record Publish Date

March 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHALIGN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 287