FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOBON®
DI: 03599870097571
·
Model: ROXLG50
·
ZimVie US Corp LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- ENDOBON®
- Primary DI
- 03599870097571
- Version / Model
- ROXLG50
- Company Name
- ZimVie US Corp LLC
- Labeler DUNS
- 119287313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-09-10
- Public Version
- 4
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- 0e4328fd-546a-41e5-8551-baa54837d9c4
Device Description
ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 5.0ML
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
- 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 |
|---|---|---|---|---|
| LYC | Bone grafting material, synthetic | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48097 | Bone matrix implant, animal-derived, non-bioabsorbable | A sterile non-bioabsorbable device made primarily of animal-derived bone matrix (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowths of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, cylinders, or granules. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03599870097571 | GS1 | ||||
| Unit of Use | 33599870097572 | GS1 |
Customer Contacts
- Phone
- +1(800)342-5454
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Particle Size 1 mm | ||
| Total Volume | 1 | Milliliter | |
| Device Size Text, specify | Particle Size 2 mm |