Duns Number:263616749
Catalog Number
-
Brand Name
I.B.S™
Version/Model Number
S80 ST435
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
K131920
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
e98d3124-f550-4d3d-9c86-290a3c0b4256
Public Version Date
May 18, 2022
Public Version Number
1
DI Record Publish Date
May 10, 2022
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 | 281 |
2 | A medical device with a moderate to high risk that requires special controls. | 608 |