CUSA SaberTip ™
- Primary DI
- 30381780026079
- Brand
- CUSA SaberTip ™
- Company
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Model
- C4616S
- Device description
- The CUSA® SaberTip™ is intended for surgical procedures where fragmentation, emulsification and aspiration of hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery. The CUSA® SaberTip™ is intended to be used for bone. Soft tissue should be avoided during use. Do not use excessive force with the CUSA® SaberTip™.
- 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 |
|---|---|---|---|---|
| 30381780026079 | Package | GS1 | 4 | In Commercial Distribution |
| 10381780026075 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30381780026079 | 30381780026079 |
| 10381780026075 | 10381780026075 |
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 |