FDA UDI
In Commercial Distribution
🇺🇸 United States
Paradigm
DI: 00850042604007
·
Model: 1100001
·
Proprio, Inc.
Product Codes
1
GMDN Terms
3
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Paradigm
- Primary DI
- 00850042604007
- Version / Model
- 1100001
- Catalog Number
- 1100003
- Company Name
- Proprio, Inc.
- Labeler DUNS
- 010254854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-05
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 1449665a-0426-4760-9708-92e0ae9904fd
Device Description
Paradigm System Cart
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
- Yes
- 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 |
|---|---|---|---|---|
| 62782 | Optical surgical navigation device tracking system | A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery]. | No | Active |
| 61496 | Surgical planning/navigation-enhancement system | A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised. | No | Active |
| 40885 | Stereotactic system application software | An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850042604007 | GS1 | ||||
| Package | 10850042604004 | GS1 | Crate | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 2068486303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222291 | 000 |