Catalog Number

53089-03

Brand Name

Alignment Arm

Version/Model Number

53089-03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K070106,K092467,K183605,K192703

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

40bd62c9-80a7-44a9-b78c-4e4405ff65dd

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

May 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-