Digital Wide Field®, Custom Color
GUDID 00811608011240
VOLK OPTICAL INC.
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.
| 00811608019765 - Mounting Kit, Alcon Revalia | 2025-04-03 |
| 00811608019772 - Mounting Kit, Takagi OM-9 | 2025-04-03 |
| 00811608019789 - Mounting Kit, Takagi OM-19 | 2025-04-03 |
| 00811608016115 - Volk SOLR Surgical System | 2025-03-19 |
| 00811608016122 - Volk SOLR Surgical System 175 | 2025-03-19 |
| 00811608016139 - Volk SOLR Rotation Base | 2025-03-17 |
| 00811608016146 - Volk SOLR Condensing Lens | 2025-03-17 |
| 00811608016603 - Volk SOLR Condensing Lens 175 | 2025-03-17 |
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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