FDA UDI
In Commercial Distribution
🇺🇸 United States
Panel PC
DI: 05065012584516
·
Model: PC001
·
EVENTUM ORTHOPAEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Panel PC
- Primary DI
- 05065012584516
- Version / Model
- PC001
- Company Name
- EVENTUM ORTHOPAEDICS LTD
- Labeler DUNS
- 226230358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-22
- Public Version
- 1
- Public Version Date
- 2025-01-30
- Public Version Status
- New
- Public Device Record Key
- addef1c8-6b4e-47dd-8869-3aafbfebc842
Device Description
Medical computer loaded with Quadsense software.
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 |
|---|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62563 | Arthroplasty force sensor display unit | An electrically-powered electronic device designed to wirelessly connect to an arthroplasty force sensor to display sensor readings in a graphical representation to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It consists of a computing device with installed dedicated application software, which may have a dedicated receiver. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065012584516 | GS1 |
Customer Contacts
- Phone
- +442045428754
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241298 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal