Catalog Number

OT 8202114

Brand Name

Operon

Version/Model Number

OT 8202114

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 11, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDC

Product Code Name

TABLE, OPERATING-ROOM, ELECTRICAL

Public Device Record Key

2e96c848-d807-400d-ac86-30277289faf0

Public Version Date

October 13, 2022

Public Version Number

2

DI Record Publish Date

August 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-