Duns Number:691435666
Device Description: ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite mate ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ReBOSSIS QDS results in a cotton-like physical form. Due to its physical form, ReBOSSIS QDS is flexible and can easily fill defects in appropriate amounts.
Catalog Number
ORB-0305D
Brand Name
ReBOSSIS QDS
Version/Model Number
0.5g
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2019
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
K170620,K172573
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
b8c51626-1291-498f-bb1d-b8232f7e1c0a
Public Version Date
November 01, 2019
Public Version Number
3
DI Record Publish Date
May 30, 2018
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. | 14 |