FDA.reportPublic FDA data

CUSA® Clarity

Primary DI
10381780466215
Brand
CUSA® Clarity
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C7523
Catalog number
C7523
Device description
CUSA® Clarity Nosecone
Published
2019-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBKDevice, neurosurgical fragmentation and aspiration
LFLInstrument, ultrasonic surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBKNeurosurgical Ultrasonic InstrumentsUnknownU
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190180000CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2019-04-01LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780466219PackageGS15In Commercial Distribution
10381780466215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178046621930381780466219
1038178046621510381780466215

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system adaptor, single-useA small, sterile, connecting device designed to fit between the component devices of an ultrasonic surgical system (i.e., the handpiece tip, handpiece, and generator) to enable them to join each other. It may include controls (e.g., buttons) that allow the operator to activate different power level settings for the system during surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Keep Dry, Do not use if package is damaged
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
989925396
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780039570Camino®PMIOMPM1PMIOMPM-12016-12-29
10381780533870CUSA® ClarityC7404SC7404S2023-06-21
10381780533894CUSA® ClarityC7404LSC7404LS2023-06-21
10381780536369CUSA® ClarityC7421SC7421S2022-11-15
10381780536383CUSA® ClarityC7523XC7523X2023-07-14
10381780536376CUSA® ClarityC7523XEAC7523XEA2023-07-14
10381780536352CUSA® ClarityC7421SEAC7421SEA2022-11-15
10381780533863CUSA® ClarityC7404SEAC7404SEA2022-09-06
10381780533887CUSA® ClarityC7404LSEAC7404LSEA2022-09-06
10381780026075CUSA® ExcelC4616SC4616S2016-12-29
10381780026082CUSA® ExcelC4617SC4617S2016-12-29
10381780248248CUSA® ExcelC4604ELTUS2016-12-29
10381780031659CUSA® ExcelC4617SEAC4617SEA2016-12-29
10381780466291Integra®PMIOMPM-1PMIOMPM-12018-05-30
10381780250074Licox®BC10PMOBC10PMO2016-08-02
10381780250043Licox®PMOCABPMOCAB2016-08-02
10381780121893Camino®BAT10012016-12-29
10381780039556Camino®CAMCABL2016-12-29
10381780121886Camino®EXPORTCABEXPORTCAB2016-12-29
10381780121879Camino®MONPWRMONPWR2016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10884521807884SonicisionCovidien LPLFL2020-06-29
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
07613327422382Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422399Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422405Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422412Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422429Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422436Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422443Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422450Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422467Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422474Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422481Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422498Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422504Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422511Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422528Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
10381780126416CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-02-08
10381780126423CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-02-08
10884521195202SonicisionCovidien LPLFL2018-08-10
10381780025535CUSA® Selector®INTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2017-01-27
10381780025993CUSA® ExcelINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2017-01-27
10381780026006CUSA® ExcelINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2017-01-27
10381780026006CUSA® ExcelINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2017-01-27
10381780040248CUSA® Selector®INTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2017-01-27
10381780040255CUSA® NXTINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2017-01-27