Acuity
GUDID 00850203008019
Rigid-gas-permeable contact lens - daily wear enflufocon A
ACUITY POLYMERS, INC.
Rigid-gas-permeable corrective contact lens, daily-wear| Primary Device ID | 00850203008019 |
| NIH Device Record Key | a6253e84-bd25-49a9-b02e-df954ce56cb7 |
| Commercial Distribution Discontinuation | 2020-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuity |
| Version Model Number | 18 |
| Company DUNS | 045438768 |
| Company Name | ACUITY POLYMERS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850203008019 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163254
FDA Product Code
| HQD | Lens, Contact (Other Material) - Daily |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-09-28 |
On-Brand Devices [Acuity]
| 00850203008033 | Rigid-gas-permeable contact lens - daily wear oprifocon A |
| 00850203008026 | Rigid-gas-permeable contact lens - daily wear enflufocon B |
| 00850203008019 | Rigid-gas-permeable contact lens - daily wear enflufocon A |
| 00850203008002 | Rigid-gas-permeable contact lens - daily wear hexafocon A |
| 00850203008330 | Rigid-gas-permeable contact lens - daily wear tisilfocon A |
| 00850203008040 | Rigid-gas-permeable contact lens - daily wear fluoroxyfocon A |
Trademark Results [Acuity]
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