| Primary Device ID | G506HOLDER010 |
| NIH Device Record Key | a317b258-e0b0-485f-bb04-4777d10c5550 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMA Optics Lens Holder |
| Version Model Number | LH-01 |
| Catalog Number | HOLDER01 |
| Company DUNS | 192827462 |
| Company Name | AMA Optics, 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G506HOLDER010 [Primary] |
| HPC | Set, Lens, Trial, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-09 |
| Device Publish Date | 2023-08-01 |
| G506NC010 - NeuroColor | 2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl |
| G506BAM010 - AMA Optics Brightness Acuity Meter | 2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare. |
| G506MACDX010 - MacDx | 2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina. |
| G506PH010 - AMA Optics Panoramic Pinhole | 2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic. |
| G506PHLC010 - AMA Optics Pinhole Clip | 2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures. |
| G506PHLC020 - RAM Panoramic Pinhole Clip | 2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo. |
| G506RAM030 - AMA Optics Retinometer | 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture |
| G506RAM040 - AMA Optics Retinometer | 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture |