FDA.reportPublic FDA data

Suction Handpiece

Primary DI
07290109142104
Brand
Suction Handpiece
Company
LUMENIS LTD.
Model
Suction Handpiece
Published
2016-11-03
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140388000LUMENIS PULSE 120HLumenis, Ltd.2014-03-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290109142101PackageGS12In Commercial Distribution
07290109142104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010914210117290109142101
07290109142104072901091421047290109142104

GMDN Terms#

Term, Definition table
TermDefinition
Suction cannula, single-useA sterile, rigid or semi-rigid, hand-held plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open- or plastic surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
408-764-3000xxx@xxx.xxx

Regulatory Flags#

DUNS number
600166524
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109140629Aspiration TubeAspiration Tube2016-08-23
07290109141923MicroSlad™ micromanipulator side-entry portMicroSlad™ micromanipulator side-entry portAA50511002016-08-30
07290109143170Moses™AC-10030100AC-100301002016-11-02
07290109143408Moses™Moses™ 365 DFLAC-100301102016-11-02
07290109143453Moses™Moses™ 550 DFLAC-100301202016-11-02
07290109140674VersaCut Control UnitVersaCut Tissue Morcellator Control Unit2016-08-23
07290109140193Slimline EZ SIS 200 FiberSlimline EZ SIS 200 Fiber2016-08-22
07290109140209Slimline EZ SIS 365 FiberSlimline EZ SIS 365 Fiber2016-08-22
07290109140216Slimline EZ SIS 550 FiberSlimline EZ SIS 550 Fiber2016-08-22
07290109140223Slimline SIS 200 FiberSlimline SIS 200 Fiber2016-08-22
07290109140230Slimline SIS 365 FiberSlimline SIS 365 Fiber2016-08-22
07290109140247Slimline SIS 550 FiberSlimline SIS 550 Fiber2016-08-22
07290109140254Slimline SIS 1000 FiberSlimline SIS 1000 Fiber2016-08-22
07290109140261Slimline™ 200 D/F/LSlimline 200 DFL FiberAC-10016352016-08-22
07290109140278Xpeeda DSL FiberXpeeda DSL FiberAC-10007292016-08-22
07290109141527AcuPulse™ Incisional Handpiece 125 mm AcuPulse™ Incisional Handpiece 125 mm AA06326002016-08-28
07290109142203SurgiTouch™ Scannerkit for AcuPulse and AcuPulse DUOKT-10001002016-08-30
07290109145662SlimLine™SlimLine™ SIS EZ 5500644-020-012022-07-25
07290109141879AcuSpotAcuSpot 712 Micromanipulator AA26300002016-09-13
07290109141916AcuSpotAcuSpot 712 L Micromanipulator AA30420002016-09-13

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