Catalog Number

-

Brand Name

Athelas Home

Version/Model Number

850-00001-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200828

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

48531e2b-3a98-4fae-8c1a-84850b9177d4

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

July 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-