| Primary Device ID | 00676190322439 |
| NIH Device Record Key | ba6912ab-f442-4a54-8c74-b74114a86f07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Superflex Collection |
| Version Model Number | SF-519 BLACK GUN |
| Company DUNS | 204096080 |
| Company Name | WestGroupe 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00676190322439 [Primary] |
| HQZ | Frame, Spectacle |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-17 |
| Device Publish Date | 2020-07-09 |
| 00676190322798 | SF-520 BROWN |
| 00676190322637 | SF-519 BROWN TAUPE |
| 00676190322590 | SF-519 BROWN TAUPE |
| 00676190322552 | SF-519 BLUE GUN |
| 00676190322514 | SF-519 BLUE GUN |
| 00676190322477 | SF-519 BLACK GUN |
| 00676190322439 | SF-519 BLACK GUN |
| 00676190322392 | SF-518 TOKYO TORTOISE |
| 00676190322354 | SF-518 TOKYO TORTOISE |
| 00676190322316 | SF-518 NAVY |
| 00676190322194 | SF-518 BLACK |
| 00676190322156 | SF-521 NAVY AQUA |
| 00676190322118 | SF-521 NAVY AQUA |
| 00676190322071 | SF-521 MAROON YELLOW |
| 00676190322033 | SF-521 MAROON YELLOW |
| 00676190321999 | SF-521 BLACK RED |
| 00676190321951 | SF-521 BLACK RED |
| 00676190315332 | SF-515 BLUE |
| 00676190315257 | SF-515 GUN |
| 00676190315219 | SF-515 GUN |
| 00676190315172 | SF-515 BROWN |
| 00676190315097 | SF-512 BROWN |
| 00676190315059 | SF-512 BROWN |
| 00676190315011 | SF-512 GREY |
| 00676190314977 | SF-512 GREY |
| 00676190314939 | SF-512 NAVY |
| 00676190314892 | SF-512 NAVY |
| 00676190314854 | SF-516 BLACK |
| 00676190314816 | SF-516 BLACK |
| 00676190314779 | SF-516 INK |
| 00676190314731 | SF-516 INK |
| 00676190314694 | SF-516 BROWN |
| 00676190314656 | SF-516 BROWN |
| 00676190314458 | SF-514 BROWN |
| 00676190314410 | SF-514 BROWN |
| 00676190314373 | SF-514 BLACK |
| 00676190314335 | SF-514 BLACK |
| 00676190314298 | SF-514 DARK GUN |
| 00676190314250 | SF-514 DARK GUN |
| 00676190314212 | SF-513 TORTOISE |
| 00676190314175 | SF-513 TORTOISE |
| 00676190314137 | SF-513 BLUE |
| 00676190314052 | SF-513 BLACK |
| 00676190314014 | SF-513 BLACK |
| 00676190311419 | SF-509 BROWN ORANGE |
| 00676190311372 | SF-509 BROWN ORANGE |
| 00676190311259 | SF-509 BLACK RED |
| 00676190311211 | SF-509 BLACK RED |
| 00676190310689 | SF-510 DARK TAUPE |
| 00676190310641 | SF-510 DARK TAUPE |