FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthAlign Plus
DI: 00858704006558
·
Model: 403008-01
·
ORTHALIGN, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OrthAlign Plus
- Primary DI
- 00858704006558
- Version / Model
- 403008-01
- Catalog Number
- 403008-01
- Company Name
- ORTHALIGN, INC.
- Labeler DUNS
- 023266163
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- f1a652e1-c752-4941-811a-c587d1b131fd
Device Description
HipAlign Instrument Tray Base
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38678 | Robotic surgical arm system | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | No | Active |
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858704006558 | GS1 |
Customer Contacts
- Phone
- 866-582-0879
- [email protected]