Duns Number:355803412
Device Description: ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 22 - 1.4 Center Point Pilo ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 22 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 22 - CePo Drills for 2.2 and 2.4 Implants1 - Manual Adaptor for R/A Driver1 - Anew Chisel-End Screwcap Driver1 - R/A Hpc Driver1 - Trephine Hollow Drill1 - Sterilizable Instrumentation Kit Box1 - Instruction for use1 - X-ray template5 - Moisture Absorbing Papers
Catalog Number
SK-3
Brand Name
Anew Surgical and Prosthetic Instrumentation Kit
Version/Model Number
SK-3
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
75e51766-50a9-44ec-8ab0-5d429607f6aa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |