Catalog Number

101-1201

Brand Name

FineEtch

Version/Model Number

101-1201

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

7e991e25-4ea3-45a7-89c2-e539bb77777a

Public Version Date

January 26, 2021

Public Version Number

6

DI Record Publish Date

February 20, 2017

Package DI Number

20200101161714

Quantity per Package

100

Contains DI Package

08809262954036

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-