FDA.reportPublic FDA data

CUSA® Excel

Primary DI
M273C3807610001
Brand
CUSA® Excel
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C380761000
Device description
The Nosecone attaches to the handpiece and covers the connecting body of the handpiece and the tip. It is designed to hold the flue in place and anchor the suction tube. Reusable nosecones are non-sterile devices.
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFLInstrument, ultrasonic surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780025870PrimaryGS10
M273C3807610001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178002587010381780025870

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece, reusableA hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable 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 (-29°F) to +65°C (149°F). Humidity: +25% to +85%. Keep dry.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
10705036035763HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035770HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035787HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-09-06
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10705036026167HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-18
10705036026174HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-11
10857156006076Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006144Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006205Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10884521807884SonicisionCovidien LPLFL2020-06-29
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
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