FDA UDI
In Commercial Distribution
🇺🇸 United States
VBR Omni™ vertebral body replacement
DI: 04052536162406
·
Model: CS 2250-26-4616
·
Ulrich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VBR Omni™ vertebral body replacement
- Primary DI
- 04052536162406
- Version / Model
- CS 2250-26-4616
- Catalog Number
- CS 2250-26-4616
- Company Name
- Ulrich GmbH & Co. KG
- Labeler DUNS
- 315494757
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-30
- Public Version
- 4
- Public Version Date
- 2022-09-14
- Public Version Status
- Update
- Public Device Record Key
- 06839b7e-7df5-4e3d-abd0-e309385e6d41
Device Description
VBR Omni, Ø 26 mm, height 46-80 mm, angle 16°
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34170 | Vertebral body prosthesis | An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04052536162406 | GS1 |
Customer Contacts
- Phone
- +4907319654152
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012254 | 000 |