FDA.report

Mini Quad XL VIT SSV (VMQXLVITSSV)

Primary DI
00811608012995
Brand
Mini Quad XL VIT SSV (VMQXLVITSSV)
Company
VOLK OPTICAL INC.
Model
VMQXLVITSSV
Published
2016-09-29
Public version status
Update
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
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811608012995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608012995008116080129958116080129950811608012995

GMDN Terms

TermDefinition
Vitrectomy contact lens, reusableA non-sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), It is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a reusable device that must be sterilized before application.

Sterilization Methods

Method

Contacts

PhoneEmail
4404635627snigdha.katragadda@volk.com
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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