FDA UDI
In Commercial Distribution
🇺🇸 United States
G21 Flex Beads, 5cc
DI: 00850018568197
·
Model: 900217 5
·
DIMENSIONAL BIOCERAMICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- G21 Flex Beads, 5cc
- Primary DI
- 00850018568197
- Version / Model
- 900217 5
- Catalog Number
- 900217 5
- Company Name
- DIMENSIONAL BIOCERAMICS LLC
- Labeler DUNS
- 080276169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-06
- Public Version
- 1
- Public Version Date
- 2024-06-14
- Public Version Status
- New
- Public Device Record Key
- ad4dd526-d239-4e88-9b03-eb849aa4de70
Device Description
CALCIUM SULFATE BONE VOID FILLER
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
- Yes
- 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 |
|---|---|---|---|---|
| 17751 | Bone matrix implant, synthetic, non-antimicrobial | A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018568197 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171161 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit