Duns Number:772462123
Device Description: Absorbable calcium salt bone void filler
Catalog Number
P822634445
Brand Name
BIOSORB
Version/Model Number
BIO1 Stick
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2020
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
K021963
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
9f6a6b9b-4f88-44fa-8b1d-6fc21f2f4660
Public Version Date
January 10, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 259 |