Duns Number:344038836
Device Description: Symbios BoneShield rectangular 33x25 mm
Catalog Number
32597402
Brand Name
Symbios®
Version/Model Number
32597402
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
JEY
Product Code Name
PLATE, BONE
Public Device Record Key
ba60bf41-4c30-476e-b88d-33db27f2f374
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
November 03, 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 | 1379 |
2 | A medical device with a moderate to high risk that requires special controls. | 2266 |