Duns Number:355280827
Device Description: GUIDE/DURA PROTECTOR for Wire Saws STILLE-GIGLI 34 cm 13 in
Catalog Number
125-19170
Brand Name
STILLE Various Instruments
Version/Model Number
125-19170
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
HAO
Product Code Name
Instrument, Surgical, Non-Powered
Public Device Record Key
dd8bb183-fe87-4a11-93be-1a99e91927fe
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 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 |