Duns Number:835233107
Device Description: SFW KIT 9736350 STEALTHAIR SPINE
Catalog Number
-
Brand Name
StealthAiR™ Spine
Version/Model Number
9736350
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
K201189
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
1094031f-4523-424b-b315-434188172be7
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |