FDA.reportPublic FDA data

TransEquator NF (VTENF)

Primary DI
00811608012582
Brand
TransEquator NF (VTENF)
Company
VOLK OPTICAL INC.
Model
VTENF
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811608012582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608012582008116080125828116080125820811608012582

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
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
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087123680Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087123697Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087123703Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122188Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-02-25
53760087123673Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-02-25
0063023812224513063 RxSight 0.766x Mag Contact LensOCULAR INSTRUMENTS, INC.HJK2019-09-11
00630238007993Hoskins-Barkan Goniotomy Adult Lens 11.5 O.D.OCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238008327Hoskins-Barkan Goniotomy Infant Lens 10mm O.D.OCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238008334Hoskins-Barkan Goniotomy Premature Lens 9mm O.D.OCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238047074Pediatric Vitrectomy Lens RingOCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238089982Disposable Vitrectomy Lens Flat, 10 PKOCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238090001Disposable Vitrectomy Lens Mag., 10 PKOCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238090018Disposable Vitrectomy Lens 30°, 10 PKOCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238090025Disposable Vitrectomy Lense Wide, 10 PKOCULAR INSTRUMENTS, INC.HJK2019-06-11
00630238090032Disposable Vitrectomy Lens 30°, 10 PKOCULAR INSTRUMENTS, INC.HJK2019-06-11