Duns Number:483599259
Device Description: Osteotome instrument kit, for bone condensation, stainless steel
Catalog Number
040.500
Brand Name
Straumann Surgical Cassettes
Version/Model Number
Surgically Invasive Instruments
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
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
65dd238d-2d09-4f7e-90da-cb42784c2892
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |