FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSA® NXT
DI: 10381780039358
·
Model: NXT10001
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CUSA® NXT
- Primary DI
- 10381780039358
- Version / Model
- NXT10001
- Catalog Number
- NXT10001
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-29
- Public Version
- 5
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- 7ad914e2-3051-4e45-87d9-f31ff25b3505
Device Description
CUSA® NXT Footswitch
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 |
|---|---|---|---|---|
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M273NXT100011 | HIBCC | ||||
| Primary | 10381780039358 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081459 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6cm (2.4in) height x 19.5cm (7.7in) width x 22cm (8.7in) depth x 5.81m (19ft) length, 2kg (4.4lbs) weight |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: +25% to +85%. Atmospheric Pressure: +500hPa to +1100hPa. Keep dry.