FDA.reportPublic FDA data

CUSA® Excel

Primary DI
10381780026136
Brand
CUSA® Excel
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C6636
Catalog number
C6636
Device description
CUSA® Excel 36 kHz CEM™ Nosecone
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780026130PackageGS16In Commercial Distribution
10381780026136PrimaryGS10
M269C66361SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178002613030381780026130
1038178002613610381780026136

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
Special Storage Condition, Specify00Temperature -34°C to 65°C; Relative Humidity 25% to 85%, non-condensing; Keep Dry.

Contacts#

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

Regulatory Flags#

DUNS number
989925396
Device count
1
Lot or batch
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