Catalog Number

11220

Brand Name

Spectra Optia®

Version/Model Number

11220

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

-

Product Code Name

-

Public Device Record Key

4d529ca2-b973-4b80-9b96-12bf7da98e2d

Public Version Date

September 02, 2022

Public Version Number

3

DI Record Publish Date

June 03, 2021

Package DI Number

35020583112200

Quantity per Package

12

Contains DI Package

05020583112209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-