Duns Number:689667152
Device Description: Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient and safe surgery with minimal error and drill heating.
Catalog Number
-
Brand Name
S-Guide Kit
Version/Model Number
FMW
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
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
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
e80c24dc-3eec-4264-9dcd-5b1236d8af36
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 13, 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 | 542 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |