Catalog Number

EX-10618

Brand Name

Excyte 20

Version/Model Number

20 (9 mm)

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

-

Product Code

GKB

Product Code Name

Device, Automated Sedimentation Rate

Public Device Record Key

7192a94e-e08e-4643-b608-33c194e8973b

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-