Catalog Number

-

Brand Name

Spectra Optia®

Version/Model Number

10110

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK120012,BK120012

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

b20d2cb9-ea51-4abc-b563-f65d455a5e4e

Public Version Date

August 09, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

35020583101105

Quantity per Package

6

Contains DI Package

05020583101104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-