FDA.reportPublic FDA data

Merlin Mount, Topcon OMS90

Primary DI
00811608018782
Brand
Merlin Mount, Topcon OMS90
Company
VOLK OPTICAL INC.
Model
11947
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00811608018782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608018782008116080187828116080187820811608018782

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811608019895GonioPro Surgical Lens + Handle (VSGLHACS)VSGLHACS2026-02-04
10811608019908Single Use GonioPro Surgical Single-Port Stabilizer (VSGSAD)VSGSAD2026-02-04
10811608019915Single Use GonioPro Surgical Multi-Port Stabilizer (VSGSBD)VSGSBD2026-02-04
10811608019922Single Use GonioPro Surgical Lens + Single-Port Stabilizer (VSGLSAD)VSGLSAD2026-02-04
10811608019939Single Use GonioPro Surgical Lens + Multi-Port Stabilizer (VSGLSBD)VSGLSBD2026-02-04
10811608019946Single Use GonioPro Surgical Lens + Handle (VSGLHD)VSGLHD2026-02-04
00811608019802Rapid SLTVLUMSLT2025-08-07
0081160801981920D Limited Edition #2V20LC-LE22025-08-01
0081160801982628D Limited Edition #2V28LC-LE22025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VPRC-LE22025-08-01
0081160801984078D Limited Edition #2V78C-LE22025-08-01
0081160801985790D Limited Edition #2V90C-LE22025-08-01
00811608019864Super 66® Limited Edition #2VS66-LE22025-08-01
00811608019871SuperField® Limited Edition #2VSFNC-LE22025-08-01
00811608019888Digital Wide Field® Limited Edition #2VDGTLWF-LE22025-08-01
00811608019376Mounting Kit, Topcon OMS-800121622025-06-30
00811608019796Mounting Kit, MediWorks SM621126552025-06-30
00811608019765Mounting Kit, Alcon Revalia126402025-03-26
00811608019772Mounting Kit, Takagi OM-9126452025-03-26
00811608019789Mounting Kit, Takagi OM-19126502025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011130734SurgiSight™ Digital Visualization HeadsetUnify Medical Inc.FSO2025-12-02
00860011130741SurgiSight™ Digital Visualization SystemUnify Medical Inc.FSO2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.FSO2025-07-15
00811608019376Mounting Kit, Topcon OMS-800VOLK OPTICAL INC.FSO2025-06-30
00811608019796Mounting Kit, MediWorks SM621VOLK OPTICAL INC.FSO2025-06-30
00811608019765Mounting Kit, Alcon RevaliaVOLK OPTICAL INC.FSO2025-03-26
00811608019772Mounting Kit, Takagi OM-9VOLK OPTICAL INC.FSO2025-03-26
00811608019789Mounting Kit, Takagi OM-19VOLK OPTICAL INC.FSO2025-03-26
06977585090013OPMI LUMERA 300Carl Zeiss Meditec (Suzhou) Co., Ltd.FSO2025-03-26
00811608016115Volk SOLR Surgical SystemVOLK OPTICAL INC.FSO2025-03-11
00811608016122Volk SOLR Surgical System 175VOLK OPTICAL INC.FSO2025-03-11
00811608016139Volk SOLR Rotation BaseVOLK OPTICAL INC.FSO2025-03-07
00811608016146Volk SOLR Condensing LensVOLK OPTICAL INC.FSO2025-03-07
00811608016603Volk SOLR Condensing Lens 175VOLK OPTICAL INC.FSO2025-03-07
00811608017259Volk SOLR Lens ArmVOLK OPTICAL INC.FSO2025-03-07
00811608017266Volk SOLR Lens Arm 175VOLK OPTICAL INC.FSO2025-03-07
00811608017273Volk SOLR Wide Angle LensVOLK OPTICAL INC.FSO2025-03-07
00811608017280Volk SOLR Mid Field LensVOLK OPTICAL INC.FSO2025-03-07
00811608017297Volk SOLR Small Wide Angle LensVOLK OPTICAL INC.FSO2025-03-07
04049539066435TIVATO® 700Carl Zeiss Meditec AGFSO2025-01-22
04250365176148ATMOSATMOS MedizinTechnik GmbH & Co. KGFSO2024-11-27
04250365176155ATMOSATMOS MedizinTechnik GmbH & Co. KGFSO2024-11-27
04250365177251ATMOSATMOS MedizinTechnik GmbH & Co. KGFSO2024-11-27
04250365177268ATMOSATMOS MedizinTechnik GmbH & Co. KGFSO2024-11-27
04049539064097KINEVO 900 SCarl Zeiss Meditec AGFSO2024-10-07
B8581023121RoboticScopeBHS Technologies GmbHFSO2024-04-03
B858138821RoboticScopeBHS Technologies GmbHFSO2024-04-03
00850007069346MaxView System - Lateral SetVISEON, INC.FSO2024-02-05
00850007069353MaxView System - Lateral SetVISEON, INC.FSO2024-02-05
00850007069360Imager Adaptor for NuVasive® MaXcess® 4 RetractorVISEON, INC.FSO2024-02-05