FDA UDI
In Commercial Distribution
🇺🇸 United States
VELYS
DI: 10705034643298
·
Model: 451611047
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VELYS
- Primary DI
- 10705034643298
- Version / Model
- 451611047
- Catalog Number
- 451611047
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-28
- Public Version
- 1
- Public Version Date
- 2025-04-07
- Public Version Status
- New
- Public Device Record Key
- d7cb9566-0541-4a55-b778-760681a8ac24
Device Description
VELYS SPINE CERVICAL CLAMP L
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47436 | Surgical optical-tracking spatial marker holder | A component of a surgical navigation and/or device tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for optical spatial markers (e.g., reflective marker spheres) that are attached to it prior to use. It can be attached to the distal end of an ultrasound transducer (US probe), neurosurgical instrument, hand-held pointer manipulated by the surgeon, or a patient reference point (e.g., head clamp), and is used as part of the tracking system to provide the correct position of the surgical devices and patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705034643298 | GS1 |