Identity
- Trade Name
- si_Mochi FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- 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 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use FDA UDI
- Model / Reference
- VET1201-O FDA UDI
- Description
- 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 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use FDA UDI
Identifiers
- Catalog Number
- VET1201-O FDA UDI
- Primary DI / UDI-DI
- 05060548020125 FDA UDI
- 510(k) Number
- K202639 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
si_Mochi by Biostone, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202639 also covers:
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- BioViveSBG — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
- OsteoXcell BA — Biostone, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biostone, Ltd.
Sources (1)
- FDA UDI adc93c7e-20b8-47fc-b395-ecc77ef112ef 35 fields · synced Jun 8, 2026