FDA.reportPublic FDA data

CUSA® Clarity

Primary DI
30381780466219
Brand
CUSA® Clarity
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C7523
Catalog number
C7523
Device description
CUSA Clarity 23kHz CEM Nosecone
Published
2019-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBKDevice, neurosurgical fragmentation and aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBKNeurosurgical Ultrasonic InstrumentsUnknownU

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@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
true
Expiration date on label
true
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 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
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2023-07-14
10381780536376CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2023-06-21
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2022-09-06
10381780533887CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2022-09-06
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-05-07
10381780126416CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-02-08
10381780126423CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-02-08
10381780466147CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466154CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466161CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466178CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466246CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780428251CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780429432CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
30381780466141CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
30381780466172CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466314CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466321CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466338CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466345CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466406CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780466413CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2019-01-16
10381780026006CUSA® ExcelINTEGRA LIFESCIENCES (IRELAND) LIMITEDLBK2017-01-27