FDA UDI
In Commercial Distribution
🇺🇸 United States
REAL INTELLIGENCE
DI: 00885556774151
·
Model: ROB100022
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REAL INTELLIGENCE
- Primary DI
- 00885556774151
- Version / Model
- ROB100022
- Catalog Number
- ROB100022
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-01
- Public Version
- 2
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 31f8535f-1295-416c-87f3-f1672b4d1ae2
Device Description
REAL INTELLIGENCE ROBOTICS CART BASE 220
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
- 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 |
|---|---|---|---|---|
| 61409 | Optical surgical navigation device tracking system workstation, mobile | A mains electricity (AC-powered) component of an optical surgical navigation device tracking system intended to act as the user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a mobile (on wheels) computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software; it may be a stand-alone unit or integrated into an endoscopic video tower or surgical pendant. The system provides an optical tool for the tracking of instruments and patient with respect to pre-acquired images (e.g., CT or MRI scan), or real-time image data [e.g., ultrasound (US) data]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885556774151 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193120 | 000 |