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

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