FDA.reportPublic FDA data

Sinon Ruby Laser System (Dummy)

Primary DI
17290110121195
Brand
Sinon Ruby Laser System (Dummy)
Company
ALMA LASERS LTD.
Model
1
Catalog number
QTL-SINON-24071203
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110121195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012119517290110121195

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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17290110122130HyLight 50 VSS Applicator for US Hybrid System1AACO090321802021-07-11
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