FDA UDI
In Commercial Distribution
🇺🇸 United States
Opus Mg Set - Mixing and Delivery System
DI: B4477120000
·
Model: AUX
·
BONE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Opus Mg Set - Mixing and Delivery System
- Primary DI
- B4477120000
- Version / Model
- AUX
- Catalog Number
- 712000
- Company Name
- BONE SOLUTIONS, INC.
- Labeler DUNS
- 003506272
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-27
- Public Version
- 2
- Public Version Date
- 2022-01-12
- Public Version Status
- Update
- Public Device Record Key
- c189583b-e961-4f76-85e3-6b312786b18a
Device Description
The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46119 | Bone graft delivery kit | A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B4477120000 | HIBCC |
Customer Contacts
- Phone
- 8178098850
- [email protected]