Catalog Number

ALN019

Brand Name

Intervertebral Body Fusion Device

Version/Model Number

ALN019

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

-

Product Code

LRY

Product Code Name

Punch, Surgical

Public Device Record Key

e3d14da2-d038-4d5e-85f1-ede417c96b7c

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-