FDA UDI
In Commercial Distribution
🇺🇸 United States
Perseus
DI: 08052675960013
·
Model: 20100801
·
ORTHOKEY ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Perseus
- Primary DI
- 08052675960013
- Version / Model
- 20100801
- Catalog Number
- 20100801
- Company Name
- ORTHOKEY ITALIA SRL
- Labeler DUNS
- 433594191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-09
- Public Version
- 1
- Public Version Date
- 2021-12-17
- Public Version Status
- New
- Public Device Record Key
- e411f66f-31b2-44ea-b610-0fed7ce690f2
Device Description
Perseus Device Sensor
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 45200 | Orthopaedic stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052675960013 | GS1 |
Customer Contacts
- Phone
- +39055354829
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192653 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 65 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius