CUSA ShearTip™
- Primary DI
- 30381780026086
- Brand
- CUSA ShearTip™
- Company
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Model
- C4617S
- Device description
- The CUSA® ShearTip™ is intended for surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery. Please see warning text in the Instructions For Use.
- 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
- true
- Single use
- true
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 |
|---|---|---|---|---|
| 30381780026086 | Package | GS1 | 4 | In Commercial Distribution |
| 10381780026082 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30381780026086 | 30381780026086 |
| 10381780026082 | 10381780026082 |
GMDN Terms#
| Term | Definition |
|---|---|
| Soft-tissue ultrasonic surgical system handpiece tip, single-use | A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Humidity | 15 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Handling Environment Humidity | 25 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -34 Degrees Celsius | 65 Degrees Celsius | |
| Handling Environment Temperature | 10 Degrees Celsius | 35 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | Keep Dry, Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | 0 | 0 | Temperature -34°C to 65°C; Relative Humidity 25% to 85%, non-condensing; Keep Dry. |
| Storage Environment Humidity | 25 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -34 Degrees Celsius | 65 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 989925396
- Device count
- 1
- 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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- 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 |