Elos Driver - A driver for a dental torque wrench for placement - Elos Medtech Pinol A/S

Duns Number:306155953

Device Description: A driver for a dental torque wrench for placement and adjustment of dental implants, abutm A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.

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More Product Details

Catalog Number

-

Brand Name

Elos Driver

Version/Model Number

C19356

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2022

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

8954a7fb-4e47-4c23-980b-e2fb04ec1352

Public Version Date

January 10, 2022

Public Version Number

3

DI Record Publish Date

March 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELOS MEDTECH PINOL A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 142