FDA.reportPublic FDA data

Merlin Mount, L 820/840/841/844

Primary DI
00811608019635
Brand
Merlin Mount, L 820/840/841/844
Company
VOLK OPTICAL INC.
Model
12160
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811608019635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608019635008116080196358116080196350811608019635

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical microscopeA general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-942-6161snigdha.katragadda@volk.com

Regulatory Flags#

DUNS number
071125835
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811608019970Mounting Kit, for Kaps SOM62121722026-04-27
00811608019987ROLS Adapter Kit, for Kaps122692026-04-27
00811608019994Single Use GonioPro Surgical Lens Sample Box (VSGSAMPLEBOX)VSGSAMPLEBOX2026-04-07
00811608012872SuperMacula VIT (VSMACVIT)VSMACVIT2016-09-29
00811608012889Central Retinal Vit (VCRLVIT)VCRLVIT2016-09-29
00811608012896Mini Quad VIT (VMQVIT)VMQVIT2016-09-29
00811608012902Dynaview 156 VIT (VDVVIT)VDVVIT2016-09-29
00811608012919Mini Quad XL VIT (VMQXLVIT)VMQXLVIT2016-09-29
00811608012971Central Retinal SSV (VCRLVITSSV)VCRLVITSSV2016-09-28
00811608012988Mini Quad SSV (VMQVITSSV)VMQVITSSV2016-09-28
00811608012995Mini Quad XL VIT SSV (VMQXLVITSSV)VMQXLVITSSV2016-09-29
00811608013053HRX Vit (VHRXVIT)VHRXVIT2016-09-29
00811608013060HRX SSV Vit (VHRXVITSSV)VHRXVITSSV2016-09-28
00811608013305HR Direct 1X Vit (VHRD1XACS)VHRD1XACS2016-09-29
00811608013312HR Direct 1X NSR Vit (VHRD1XNSRACS)VHRD1XNSRACS2016-09-29
00811608013336HR Direct Bi-Concave (VHRDBCACS)VHRDBCACS2016-09-29
00811608013343HR Direct HighMag Vit (VHRDHMACS)VHRDHMACS2016-09-29
00811608013350HR Direct HM NSR Vit (VHRDHMNSRACS)VHRDHMNSRACS2016-09-29
00811608013183Flat SSV ACS (VFLATSSVACS)VFLATSSVACS2016-09-29
0081160801319015 Prism SSV ACS (VPRISMSSVACS)VPRISMSSVACS2016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811608019970Mounting Kit, for Kaps SOM62VOLK OPTICAL INC.FSO2026-04-27
00811608019987ROLS Adapter Kit, for KapsVOLK OPTICAL INC.FSO2026-04-27
00860011130734SurgiSight™ Digital Visualization HeadsetUnify Medical Inc.FSO2025-12-02
00860011130741SurgiSight™ Digital Visualization SystemUnify Medical Inc.FSO2025-12-02
06945095524779zumaxZumax Medical Co., LTDFSO2025-10-28
06945095524991zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525097zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525134zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525462zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525486zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525493zumaxZumax Medical Co., LTDFSO2025-10-28
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06945095525578zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525660zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525677zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525745zumaxZumax Medical Co., LTDFSO2025-10-28
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06945095526261zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526322zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526339zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526360zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526421zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526476zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526513zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526544zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526568zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526575zumaxZumax Medical Co., LTDFSO2025-10-28