Drill S-5.5, 3.2/2.5mmDx13.0mmL - ADIN DENTAL IMPLANT SYSTEMS LTD

Duns Number:533289435

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More Product Details

Catalog Number

-

Brand Name

Drill S-5.5, 3.2/2.5mmDx13.0mmL

Version/Model Number

GS1332

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

EJL

Product Code Name

Bur, Dental

Device Record Status

Public Device Record Key

7a1f8d29-bc7d-4db6-a155-1bb265956440

Public Version Date

December 04, 2020

Public Version Number

1

DI Record Publish Date

November 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADIN DENTAL IMPLANT SYSTEMS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 483
2 A medical device with a moderate to high risk that requires special controls. 892