Catalog Number

1700300-001

Brand Name

Set OSSEOUNO + S120

Version/Model Number

1700300

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

-

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

ERL

Product Code Name

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Public Device Record Key

d83bade6-7df1-4d56-815d-eaa099c4dfaf

Public Version Date

February 07, 2019

Public Version Number

1

DI Record Publish Date

January 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-