FDA UDI
In Commercial Distribution
🇺🇸 United States
CUSA® NXT
DI: 10381780039303
·
Model: CUSANXT2
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CUSA® NXT
- Primary DI
- 10381780039303
- Version / Model
- CUSANXT2
- Catalog Number
- CUSANXT2
- 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
- f6aba853-5bd4-4c83-8484-e10d77562547
Device Description
CUSA® NXT2 Service Module 230V
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 |
|---|---|---|---|---|
| 37776 | Ultrasonic suction system | An assembly of mains electricity (AC-powered) devices designed to use mechanical ultrasonic vibration and a combination of irrigation and suction to fragment and remove soft tissue and growths of high water content from various parts of the body. Ultrasonic suction units are used during neurosurgery, general surgery, and gynaecological and orthopaedic procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M273CUSANXT21 | HIBCC | ||||
| Primary | 10381780039303 | 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 | Service Module 87.6cm (34.5 in) height x 50.3cm (19.8in) width x 76.6cm (28.6in) depth, 45.4kg (100lbs) 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.