FDA.reportPublic FDA data

TransEquator (VTE)

Primary DI
00811608012476
Brand
TransEquator (VTE)
Company
VOLK OPTICAL INC.
Model
VTE
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJILens, Fundus, Hruby, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJILens, Fundus, Hruby, DiagnosticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811608012476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608012476008116080124768116080124760811608012476

GMDN Terms#

Term, Definition table
TermDefinition
Laser lens, ophthalmic, surgicalA device designed to modify the convergence of the rays of light of an ophthalmic laser beam used to coagulate or cut tissues of the eye, the orbit, or the surrounding skin.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4404635627snigdha.katragadda@volk.com
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
07612717071285Alcon GrieshaberAlcon Laboratories, Inc.HJI2020-08-19
17612717071282Alcon GrieshaberAlcon Laboratories, Inc.HJI2020-08-19
00192896009486HEINE OMEGA 180SONTEC INSTRUMENTS, INC.HJI2018-08-15
00192896009493HEINE OMEGA 180SONTEC INSTRUMENTS, INC.HJI2018-08-15
00811608012483PDT Laser (VPDT)VOLK OPTICAL INC.HJI2016-09-29