FDA.reportPublic FDA data

CUSA® Clarity

Primary DI
30381780466172
Brand
CUSA® Clarity
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C7420S
Catalog number
C7420S
Device description
CUSA Clarity 23kHz Bone 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
30381780466172PackageGS15In Commercial Distribution
10381780466178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178046617230381780466172
1038178046617810381780466178

GMDN Terms#

Term, Definition table
TermDefinition
Hard-tissue ultrasonic surgical system handpiece tipA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. 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
30381780466141CUSA® 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