Duns Number:355280827
Device Description: HAND OSTEOTOME STILLE 8 mm curved blade R45 mm phenolic handle 16 cm 6.25 in
Catalog Number
100-111-0083
Brand Name
STILLE Osteotomes
Version/Model Number
100-111-0083
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDG
Product Code Name
Chisel (Osteotome)
Public Device Record Key
3a62a37d-6682-45a8-8519-e78f29d84720
Public Version Date
November 16, 2020
Public Version Number
1
DI Record Publish Date
November 06, 2020
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 | 1073 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |