FDA.reportPublic FDA data

Visualase

Primary DI
00643169933361
Brand
Visualase
Company
MEDTRONIC NAVIGATION, INC.
Model
9735559
Device description
VCLAS 9735559 3MM TIP/1.65MM CATHETER
Published
2017-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument
ONONeurosurgical laser with MR thermography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONONeurosurgical Laser With Mr ThermographyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169933361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169933361006431699333616431699333610643169933361

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835233107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150054398StealthStation S897357622026-08-07
00199150054466N/A97367262026-08-08
00199150057078AXIS AP ROBOTIC TOOL CHANGER 973668197366812026-08-09
00199150067626KIT 9736691 SPINE REFERENCING97366912026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALL97364332026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUM97364652026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORT97364342026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUM97364672026-08-07
00763000381141N/A97314602026-08-08
00763000989927AXIS HYBRID REF FRAME 973651197365112026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 973651397365132026-08-07
00763000539238SteathStation97364262023-08-04
00763000539108SteathStation97364232022-02-07
00763000539177SteathStation97364262022-02-07
00763000914097Stealth AXiS97365032026-07-24
00763000914035Stealth AXiS97364812026-07-17
00763000914042Stealth AXiS97364822026-07-17
00763000914059Stealth AXiS97364832026-07-17
00763000914066Stealth AXiS97364842026-07-17
00763000914073Stealth AXiS97364852026-07-17

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