CUSA® Excel
- Primary DI
- M248C00051
- Brand
- CUSA® Excel
- Company
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Model
- C0005
- Device description
- Excel Contamination Guard BOX2: The Contamination Guard is compatible with the CUSA® Excel family of Ultrasonic Surgical Aspirator systems. The CUSA Excel Contamination Guard is a mechanical shut off valve that prevents liquids and aspirated tissue from reaching the vacuum pump. The Contamination Guard packing contains two (2) individual, non-sterile, Contamination Guards. The Contamination Guard is sold non-sterile. The contamination guard will be changed at maximum every six months or sooner if necessary.
- Published
- 2016-12-29
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| LBK | Device, neurosurgical fragmentation and aspiration |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LBK | Neurosurgical Ultrasonic Instruments | Unknown | U |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780025825 | Primary | GS1 | 0 | |
| M248C00051 | Secondary | HIBCC | 0 | |
| 00381780025828 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10381780025825 | 10381780025825 | ||
| 00381780025828 | 00381780025828 | 381780025828 | 0381780025828 |
GMDN Terms#
| Term | Definition |
|---|---|
| Soft-tissue ultrasonic surgical system | An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Temperature -34°C to +65°C; Humidity 25% to 85%;Keep Dry |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 989925396
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780039570 | Camino® | PMIOMPM1 | PMIOMPM-1 | 2016-12-29 |
| 10381780533870 | CUSA® Clarity | C7404S | C7404S | 2023-06-21 |
| 10381780533894 | CUSA® Clarity | C7404LS | C7404LS | 2023-06-21 |
| 10381780536369 | CUSA® Clarity | C7421S | C7421S | 2022-11-15 |
| 10381780536383 | CUSA® Clarity | C7523X | C7523X | 2023-07-14 |
| 10381780536376 | CUSA® Clarity | C7523XEA | C7523XEA | 2023-07-14 |
| 10381780536352 | CUSA® Clarity | C7421SEA | C7421SEA | 2022-11-15 |
| 10381780533863 | CUSA® Clarity | C7404SEA | C7404SEA | 2022-09-06 |
| 10381780533887 | CUSA® Clarity | C7404LSEA | C7404LSEA | 2022-09-06 |
| 10381780026075 | CUSA® Excel | C4616S | C4616S | 2016-12-29 |
| 10381780026082 | CUSA® Excel | C4617S | C4617S | 2016-12-29 |
| 10381780248248 | CUSA® Excel | C4604ELTUS | 2016-12-29 | |
| 10381780031659 | CUSA® Excel | C4617SEA | C4617SEA | 2016-12-29 |
| 10381780466291 | Integra® | PMIOMPM-1 | PMIOMPM-1 | 2018-05-30 |
| 10381780250074 | Licox® | BC10PMO | BC10PMO | 2016-08-02 |
| 10381780250043 | Licox® | PMOCAB | PMOCAB | 2016-08-02 |
| 10381780121893 | Camino® | BAT1001 | 2016-12-29 | |
| 10381780039556 | Camino® | CAMCABL | 2016-12-29 | |
| 10381780121886 | Camino® | EXPORTCAB | EXPORTCAB | 2016-12-29 |
| 10381780121879 | Camino® | MONPWR | MONPWR | 2016-12-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10381780536383 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2023-07-14 |
| 10381780536376 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2023-07-14 |
| 10381780533870 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2023-06-21 |
| 10381780533894 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2023-06-21 |
| 10381780536369 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2022-11-15 |
| 10381780536352 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2022-11-15 |
| 10381780533863 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2022-09-06 |
| 10381780533887 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2022-09-06 |
| 10381780466215 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-05-07 |
| 30381780466219 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-05-07 |
| 10381780466383 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-05-07 |
| 10381780126416 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-02-08 |
| 10381780126423 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-02-08 |
| 10381780466147 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466154 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466161 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466178 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466246 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780428251 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780429432 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 30381780466141 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 30381780466172 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466314 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466321 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466338 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466345 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466352 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466369 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466406 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |
| 10381780466413 | CUSA® Clarity | INTEGRA LIFESCIENCES (IRELAND) LIMITED | LBK | 2019-01-16 |