Duns Number:222236587
Device Description: Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1 cc suspended in a biocompatible hydrogel solution packed in a capped 10 cm cartridge with a sealed O-ring plunger. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box.
Catalog Number
OBS1201
Brand Name
si_Mochi
Version/Model Number
OBS1201
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
K202639
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
f229c883-76fe-4c85-8864-1763fb4b03f1
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |