FDA.reportPublic FDA data

CUSA® Clarity

Primary DI
30381780126304
Brand
CUSA® Clarity
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C7602
Device description
CUSA Clarity 36kHz Torque Wrench
Published
2016-11-23
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
K161882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161882000CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2016-10-14LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780126304PackageGS15In Commercial Distribution
10381780126300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178012630430381780126304
1038178012630010381780126300

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system torque wrench, single-useA sterile hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. 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
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
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