FDA UDI
In Commercial Distribution
🇺🇸 United States
BonOs HV Genta
DI: 04260056882623
·
Model: 1x40
·
OSARTIS GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BonOs HV Genta
- Primary DI
- 04260056882623
- Version / Model
- 1x40
- Catalog Number
- 01-0262
- Company Name
- OSARTIS GmbH
- Labeler DUNS
- 344261631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-03
- Public Version
- 1
- Public Version Date
- 2024-04-11
- Public Version Status
- New
- Public Device Record Key
- b635a1de-318d-43af-ae75-16eead8bc479
Device Description
BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| MBB | Bone Cement, Antibiotic | Orthopedic | 888.3027 | 2 |
| LOD | Bone Cement | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46059 | Orthopaedic cement, antimicrobial | A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260056882623 | GS1 | ||||
| Package | 14260056882620 | GS1 | Shipping unit | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210125 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 40.8 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 0°C (32°F) and 25°C (77°F)
- Type
- Handling Environment Temperature
- Temperature Range
- 17 – 25 Degrees Celsius