FDA.reportPublic FDA data

CUSA® Excel

Primary DI
M273C26011
Brand
CUSA® Excel
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C2601
Device description
The CUSA Excel handpieces are connected to the consoles. The handpiece houses the transducer and an electric coil which generate the magnetic field. Alternating the magnetic field causes the transducer to expand and contract and results in motion. The motion is amplified by the transducer and causes the CUSA Excel tip to create a motion of up to 350microns at the tip end. A variety of tips can be used with each handpiece.
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
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
10381780039426PrimaryGS10
M273C26011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003942610381780039426

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). Relative Humidity, non-condensing: +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
false
Serial number
true
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
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