Digital Wide Field®, Custom Color
GUDID 00811608011240
VOLK OPTICAL INC.
Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens| Primary Device ID | 00811608011240 |
| NIH Device Record Key | a23f7cf1-e182-4a93-b0fd-ae5300d63ce5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Digital Wide Field®, Custom Color |
| Version Model Number | VDGTLWF-CC |
| Company DUNS | 071125835 |
| Company Name | VOLK OPTICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811608011240 [Primary] |
FDA Product Code
| HJL | Lens, Condensing, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-25 |
| Device Publish Date | 2021-01-15 |
Devices Manufactured by VOLK OPTICAL INC.
| 00811608014708 - Volk Viva | 2024-04-15 |
| 00811608014739 - Volk Viva | 2024-04-15 |
| 10811608014675 - Single Use Indirect Wide Field (VVITSSVDH) | 2023-10-27 |
| 00811608013770 - Volk VistaView | 2022-11-24 |
| 00811608014586 - VistaView Slit Lamp Adapter | 2022-11-24 |
| 00811608019703 - Virtual by Volk Telemedicine Software | 2021-11-18 |
| 00811608011240 - Digital Wide Field®, Custom Color | 2021-01-25 |
| 00811608011240 - Digital Wide Field®, Custom Color | 2021-01-25 |
| 00811608011332 - Super 66® Stereo Fundus | 2020-10-05 |
Trademark Results [Digital Wide Field]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGITAL WIDE FIELD 78824569 3228940 Live/Registered |
Volk Optical Inc. 2006-02-27 |
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