FDA.reportPublic FDA data

Ultra V UltraBody Handpiece

Primary DI
17290110120204
Brand
Ultra V UltraBody Handpiece
Company
ALMA LASERS LTD.
Model
1
Catalog number
AAUN27121004
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072699000ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLAlma Lasers , Ltd.2007-10-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110120204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012020417290110120204

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

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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17290110120952CO2 New Scanner system 100-120V 30W1AACO010212032016-09-24
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