FDA UDI
In Commercial Distribution
🇺🇸 United States
CD HORIZON® SOLERA® VOYAGER™ Spinal System
DI: 00643169491120
·
Model: 1664006
·
MEDTRONIC SOFAMOR DANEK, INC.
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CD HORIZON® SOLERA® VOYAGER™ Spinal System
- Primary DI
- 00643169491120
- Version / Model
- 1664006
- Company Name
- MEDTRONIC SOFAMOR DANEK, INC.
- Labeler DUNS
- 830350380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 9
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 67cb5015-3a91-4c88-9e4b-22243775f6a7
Device Description
LID 1664006 TAB EXTENDER CAP CADDY LID
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION | Orthopedic | 888.3070 | 2 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
| OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis | Orthopedic | 888.3070 | 2 |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169491120 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143375 | 000 |