Catalog Number

43064020

Brand Name

Aggeris™-C

Version/Model Number

43064020

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

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

K220182

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Public Device Record Key

60bbc535-51e8-49af-b5cc-c6c1fd01731c

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-