FDA.report

Disposable Direct Image 30 Prism (V30PD)

Primary DI
30811608017205
Brand
Disposable Direct Image 30 Prism (V30PD)
Company
VOLK OPTICAL INC.
Model
V30PD
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
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10811608017201PackageGS110In Commercial Distribution
20811608017208PackageGS1100In Commercial Distribution
30811608017205PackageGS1800In Commercial Distribution
00811608017204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081160801720110811608017201
2081160801720820811608017208
3081160801720530811608017205
00811608017204008116080172048116080172040811608017204

GMDN Terms

TermDefinition
Vitrectomy contact lens, single-useA 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 single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
4409426161bernie.rykaczewski@volk.com
440-942-6161snigdha.katragadda@volk.com

Regulatory Flags

DUNS number
071125835
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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