Catalog Number

-

Brand Name

Spectra Optia®

Version/Model Number

11300

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

-

Product Code

PKG

Product Code Name

Bone marrow processing device to support hematopoietic reconstitution

Public Device Record Key

d23a379a-8355-48d6-a2ee-6e0b43a4c8dd

Public Version Date

August 09, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

35020583113009

Quantity per Package

6

Contains DI Package

05020583113008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-