Catalog Number

100353

Brand Name

Osstell SmartPeg Type 01

Version/Model Number

Osstell SmartPeg Type 01

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

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

64ff591e-c2c8-4500-a33d-3e7db6051c54

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

09010522000021

Quantity per Package

5

Contains DI Package

09010522001165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box