Catalog Number

OB-13

Brand Name

3M™ ESPE™ MDI Standard O-Ball and Collar

Version/Model Number

1.8 mm x 13 mm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

3ba09295-a79f-4a26-9ad4-d4928fe0450e

Public Version Date

September 30, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-