FDA.report

VASER

Primary DI
00816995026327
Brand
VASER
Company
SOLTA MEDICAL
Model
130-0118
Catalog number
130-0118
Device description
SKIN PORT, ORANGE DISC, 12PK
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications

CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816995026327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995026327008169950263278169950263270816995026327

GMDN Terms

TermDefinition
Ultrasonic surgical system generatorAn electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
079999584
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00816995022978ORIGINS810-MDMD5030PXNR810-MDMD5030PXNR2022-04-08
00816995023005ORIGINS810-MDMD6030PXNR810-MDMD6030PXNR2022-04-08
00816995023050ORIGINS810-SGBU4030PXNR810-SGBU4030PXNR2022-04-08
00816995023173ORIGINS810-SLBU4026PXNR810-SLBU4026PXNR2022-04-08
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