Catalog Number

OTO-IN 36 00-N

Brand Name

OTELO INSTRUMENTATION

Version/Model Number

OTO-IN 36 00-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2019

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

-

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

GAD

Product Code Name

Retractor

Public Device Record Key

e0fb138c-61d6-4751-82a3-73c9a5742e3b

Public Version Date

February 06, 2019

Public Version Number

2

DI Record Publish Date

July 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-