FDA.report

Merlin Mount, Leica M690

Primary DI
00811608019642
Brand
Merlin Mount, Leica M690
Company
VOLK OPTICAL INC.
Model
12159
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

Related Records

Contact Domains

Product Codes

CodeName
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811608019642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608019642008116080196428116080196420811608019642

GMDN Terms

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

Contacts

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

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0081160801981920D Limited Edition #2V20LC-LE22025-08-01
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