FDA.reportPublic FDA data

CUSA® Clarity

Primary DI
30381780466141
Brand
CUSA® Clarity
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C7401S
Catalog number
C7401S
Device description
CUSA Clarity 23kHz Standard Tip
Published
2019-01-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780466141PackageGS15In Commercial Distribution
10381780466147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178046614130381780466141
1038178046614710381780466147

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece tip, single-useA 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.

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
true
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
30381780466219CUSA® 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
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