FDA.report

Volk Pictor VP1Handset, VP1RET, VP1ANT, VP1OTO, & VP1DERM

Primary DI
00811608018065
Brand
Volk Pictor VP1Handset, VP1RET, VP1ANT, VP1OTO, & VP1DERM
Company
VOLK OPTICAL INC.
Model
VP1COMPK
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811608018065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811608018065008116080180658116080180650811608018065

GMDN Terms

TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

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
false
Premarket exempt
true
HCT/P
false
Kit
true
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 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