RS-Standard Internal Hex  Plastic Surgical Kit-Advanced  Short Drills - ADIN DENTAL IMPLANT SYSTEMS LTD

Duns Number:533289435

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

RS-Standard Internal Hex  Plastic Surgical Kit-Advanced  Short Drills

Version/Model Number

RS6324

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

OFY

Product Code Name

Dental Implant Surgical Tray

Device Record Status

Public Device Record Key

ba34581d-0182-4f0a-b2a3-5dc2faeabc0c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 23, 2017

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