FDA.reportPublic FDA data

Visualase

Primary DI
00643169933408
Brand
Visualase
Company
MEDTRONIC NAVIGATION, INC.
Model
9735570
Device description
ACCESSORY KIT 9735570 VISUALASE BODY
Published
2018-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBMCannula and trocar, suprapubic, non-disposable
GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169933408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169933408006431699334086431699334080643169933408

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
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000404871StealthStation™97359632026-05-23
00199150006427Stealth AXiS97365512026-04-24
00199150071586Stealth AXiS97367642026-04-19
00199150071609Stealth AXiS97367662026-04-19
00763000928896Stealth AXiS97365172026-04-11
00763000928902Stealth AXiS97365182026-04-11
00763000928919Stealth AXiS97365212026-04-10
00763000928926Stealth AXiS97365332026-04-10
00763000945947Stealth AXiS97365202026-04-10
00763000945954Stealth AXiS97365192026-04-10
00763000983840Stealth AXiS97366782026-04-11
00763000983864Stealth AXiS97366792026-04-11
00763000983888Stealth AXiS97366802026-04-11
00763000984441Stealth AXiS97364812026-04-10
00763000984458Stealth AXiS97364822026-04-10
00763000984465Stealth AXiS97364832026-04-10
00763000984472Stealth AXiS97364842026-04-10
00763000984489Stealth AXiS97364852026-04-10
00763000984496Stealth AXiS97364862026-04-10
00763000984502Stealth AXiS97365032026-04-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10653405045090CORE DYNAMICSConmed CorporationFBM2026-03-24
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14026704920621KMEDICTELEFLEX INCORPORATEDGAH2024-07-15
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
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M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
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10850082007896MedDrainARMM INC.KGZ2023-06-08
10850082007902MedDrainARMM INC.KGZ2023-06-08
10850082007919MedDrainARMM INC.KGZ2023-06-08
10850082007995MedDrainARMM INC.KGZ2023-06-08
10801902201048ARROWTELEFLEX INCORPORATEDKGZ2022-11-09
10801902201055ARROWTELEFLEX INCORPORATEDKGZ2022-11-09
10801902208450ARROWTELEFLEX INCORPORATEDKGZ2022-11-09