CUSA® Excel MacroTip ™

Primary DI
30381780025959
Brand
CUSA® Excel MacroTip ™
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
C4605S
Device description
Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. This System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
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
true
Single use
true

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
30381780025959PackageGS14In Commercial Distribution
10381780025955PrimaryGS10
M269C4605S17SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178002595930381780025959
1038178002595510381780025955

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece tip, single-useA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). 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.

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30381780039444CUSA® NXTNXT32182016-12-29
30381780039468CUSA® NXTNXT32192016-12-29
30381780039482CUSA® NXTNXT32202016-12-29
30381780040365CUSA® Selector®15232352017-01-27
30381780121972CUSA® Selector®15232152017-01-27
M610152324315CUSA® NXT15232432016-12-29
10381780040712CUSA® Selector®15230452016-12-29
10381780040408CUSA® Selector®1523072M22016-12-29
10381780039617Camino®AP062016-12-29
10381780039655Camino®AP192016-12-29
10381780536376CUSA® ClarityC7523XEAC7523XEA2023-07-14
30381780536387CUSA® ClarityC7523XC7523X2023-07-14
30381780533874CUSA® ClarityC7404SC7404S2023-06-21
30381780533898CUSA® ClarityC7404LSC7404LS2023-06-21
M273NXT800011CUSA® NXTNXT800012016-12-29
M273NXT800021CUSA® NXTNXT800022016-12-29
M273NXT800031CUSA® NXTNXT800032016-12-29
M269NXT3218EA1CUSA® NXTNXT3218EA2016-12-29
10381780039471CUSA® NXTNXT3219EA2017-01-27
10381780039495CUSA® NXTNXT3220EA2017-01-27

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