FDA UDI
In Commercial Distribution
🇺🇸 United States
NuROs Bone Graft Substitute(Sterile)
DI: 04716329941141
·
Model: BGD50
·
ORIENTAL RESOURCES DEVELOPMENT LIMITED BIOMEDICAL FACTORY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NuROs Bone Graft Substitute(Sterile)
- Primary DI
- 04716329941141
- Version / Model
- BGD50
- Company Name
- ORIENTAL RESOURCES DEVELOPMENT LIMITED BIOMEDICAL FACTORY
- Labeler DUNS
- 658871135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-20
- Public Version
- 1
- Public Version Date
- 2019-05-28
- Public Version Status
- New
- Public Device Record Key
- 20073f90-1949-49c1-858f-074ce5f4a094
Device Description
NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Absorbable Bone Graft Substitute is absorbed around 6 months and replaced with bone during the healing process.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04716329941141 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140913 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Millimeter | |
| Total Volume | 2.5 | Milliliter |