FDA UDI
In Commercial Distribution
🇺🇸 United States
Quadsense Pro
DI: 05065012584493
·
Model: SE002
·
EVENTUM ORTHOPAEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Quadsense Pro
- Primary DI
- 05065012584493
- Version / Model
- SE002
- Company Name
- EVENTUM ORTHOPAEDICS LTD
- Labeler DUNS
- 226230358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 1
- Public Version Date
- 2025-04-14
- Public Version Status
- New
- Public Device Record Key
- 54d0067f-760c-4cf9-8e00-539a9410ed99
Device Description
Single Use 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
- No
- 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 |
|---|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58988 | Arthroplasty force sensor | An electronic device designed for use during arthroplasty to facilitate assessment of joint function during implantation of prosthesis components, typically to evaluate bone resection lines, prosthesis size and positioning, and/or soft tissue tension. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or communicate with an external display unit; some types include a noninvasive analogue-to-digital converter and image display controller. It is typically available as a left or right version. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065012584493 | 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