Duns Number:315427286
Device Description: SUS³ telescope rods / Sabbagh Universal Spring / For further information please visit our SUS³ telescope rods / Sabbagh Universal Spring / For further information please visit our online-shop on our website www.dentaurum.de
Catalog Number
-
Brand Name
N.A.
Version/Model Number
607-159-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
DYJ
Product Code Name
RETAINER, SCREW EXPANSION, ORTHODONTIC
Public Device Record Key
9fb83ba8-224b-4404-9a0d-930bc1343ab1
Public Version Date
November 16, 2021
Public Version Number
3
DI Record Publish Date
September 18, 2019
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |