CUSA® Clarity C7523XEA
GUDID 10381780536376
CUSA Clarity 23kHz Expanded CEM Nosecone (Single Pack)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Ultrasonic surgical system adaptor, single-use| Primary Device ID | 10381780536376 |
| NIH Device Record Key | 26db582c-ef3f-45fd-99d3-2705e3063c1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSA® Clarity |
| Version Model Number | C7523XEA |
| Catalog Number | C7523XEA |
| Company DUNS | 989925396 |
| Company Name | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Do not use if package is damaged |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780536376 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230427
FDA Product Code
| LFL | Instrument, ultrasonic surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-24 |
| Device Publish Date | 2023-07-14 |
On-Brand Devices [CUSA® Clarity]
| 10381780357483 | CUSA Clarity replacement 36kHz handpiece |
| 10381780126461 | CUSA Clarity Cleaning Brush |
| 10381780126263 | CUSA Clarity 36kHz Handpiece |
| 10381780126256 | CUSA Clarity Footswitch |
| 10381780251316 | CUSA Clarity 36kHz Standard Tip |
| 30381780251303 | CUSA Clarity 36kHz Standard Tip |
| 10381780126478 | CUSA Clarity Specimen Trap (Sock Insert) |
| 10381780126454 | CUSA Clarity 36kHz Curved Extended ShearTip |
| 10381780126447 | CUSA Clarity 36kHz Curved Extended MicroTip Plus |
| 10381780126430 | CUSA Clarity 36kHz Curved Extended Standard Tip |
| 10381780126409 | CUSA Clarity 36kHz Curved Extended MicroTip |
| 30381780126380 | CUSA Clarity 36kHz Curved Extended ShearTip |
| 30381780126373 | CUSA Clarity 36kHz Curved Extended MicroTip Plus |
| 30381780126366 | CUSA Clarity 36kHz Curved Extended Standard Tip |
| 30381780126359 | CUSA Clarity 36kHz Curved Extended MicroTip |
| 10381780126324 | CUSA Clarity Contamination Guard |
| 10381780126317 | CUSA Clarity 36kHz Torque Wrench |
| 30381780126304 | CUSA Clarity 36kHz Torque Wrench |
| 10381780126294 | CUSA Clarity Quick Connect Cartridge and Tubing Set |
| 30381780126281 | CUSA Clarity Quick Connect Cartridge and Tubing Set |
| 10381780126423 | Extended Use Standard Tip (EUT) Pack 36kHz: Tip, Flue Assembly, Nosecone, Tip Cleaner |
| 10381780126416 | Extended Use Curved MicroTip (EUT) Pack 36kHz: Tip, Flue Assembly, Nosecone, Tip Cleaner |
| 10381780466413 | CUSA Clarity 23kHz Cleaning Brush |
| 10381780466406 | CUSA Clarity 23kHz Torque Wrench |
| 10381780466369 | CUSA Clarity 23kHz Bone Tip |
| 10381780466352 | CUSA Clarity 23kHz Tough Tissue Tip |
| 10381780466345 | CUSA Clarity 23kHz Macro Tip |
| 10381780466338 | CUSA Clarity 23kHz Standard Tip |
| 10381780466321 | CUSA Clarity 23kHz Handpiece (Rapid Replacement) |
| 10381780466314 | CUSA Clarity 23kHz Handpiece |
| 30381780466240 | CUSA Clarity 23kHz Torque Wrench |
| 30381780466172 | CUSA Clarity 23kHz Bone Tip |
| 30381780466165 | CUSA Clarity 23kHz Tough Tissue Tip |
| 30381780466158 | CUSA Clarity 23kHz Macro Tip |
| 30381780466141 | CUSA Clarity 23kHz Standard Tip |
| 10381780429432 | CUSA Clarity 23kHz Sterilization Tray |
| 10381780428251 | CUSA Clarity 23kHz Torque Base |
| 10381780357438 | CUSA Clarity Cart used for portability between hospitals |
| 10381780126485 | CUSA Clarity 36kHz Torque Base |
| 10381780126270 | CUSA Clarity 36kHz Sterilization Tray |
| 10381780126249 | CUSA Clarity Custom Cart |
| 10381780126232 | CUSA Clarity Ultrasonic Surgical Aspirator System |
| 10381780533887 | 23kHz Extended Length Laparoscopic Tip |
| 10381780533863 | 23kHz Standard Length Laparoscopic Tip |
| 10381780466383 | CUSA Clarity 23kHz CEM Nosecone |
| 30381780466219 | CUSA Clarity 23kHz CEM Nosecone |
| 30381780536363 | CUSA Clarity 23kHz Single-Sided Bone Tip (Five Pack) |
| 10381780536352 | CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack) |
| 30381780533898 | CUSA Clarity 23kHz Extended Laparoscopic Tip (Five Pack) |
| 30381780533874 | CUSA Clarity 23kHz Standard Laparoscopic Tip (Five Pack) |
Trademark Results [CUSA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUSA 97880179 not registered Live/Pending |
Conference USA, Inc. 2023-04-10 |
 CUSA 86488383 5055280 Live/Registered |
Credentialing USA, Inc. 2014-12-22 |
 CUSA 86386901 5105500 Live/Registered |
Credentialing USA, Inc. 2014-09-05 |
 CUSA 85226675 4012505 Live/Registered |
Fiserv, Inc. 2011-01-26 |
 CUSA 78914847 not registered Dead/Abandoned |
Corrections U.S.A. 2006-06-22 |
 CUSA 78262975 2946715 Dead/Cancelled |
CUSA, LLC 2003-06-16 |
 CUSA 76311200 2639112 Dead/Cancelled |
NATIONAL SAFETY COUNCIL, 2001-09-07 |
 CUSA 75703117 2437564 Dead/Cancelled |
NATIONAL SAFETY COUNCIL 1999-05-11 |
 CUSA 75574524 2396920 Dead/Cancelled |
Capital USA LLC 1998-10-21 |
 CUSA 73746855 1648672 Dead/Cancelled |
CUSA, INC. 1988-08-18 |
 CUSA 73746854 1659473 Dead/Cancelled |
CUSA, INC. 1988-08-18 |
 CUSA 73584520 1412194 Live/Registered |
COOPER LASERSONICS, INC. 1986-02-24 |
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