| Primary Device ID | 04582697820223 |
| NIH Device Record Key | 6b105a81-5831-4ee4-91a8-9cce51dc525a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPECWELL |
| Version Model Number | M0412 (12x) |
| Company DUNS | 701065054 |
| Company Name | SPECWELL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04582697820223 [Primary] |
| HKB | Telescope, Hand-Held, Low-Vision |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2022-09-24 |
| 04582697820360 | M820-SM (Pasco) |
| 04582697820353 | M0725 (IPG) |
| 04582697820346 | M820-C (25x) |
| 04582697820339 | M820-C (35x) |
| 04582697820322 | M1030 (30x) |
| 04582697820315 | M1030 (45x) |
| 04582697820308 | M0830 (25x) |
| 04582697820292 | M0830 (40x) |
| 04582697820285 | M0725 (30x) |
| 04582697820278 | M0820 (25x) |
| 04582697820261 | M0820 (35x) |
| 04582697820254 | M0616 (20x) |
| 04582697820247 | M0616 (25x) |
| 04582697820230 | M0412 (16x) |
| 04582697820223 | M0412 (12x) |
| 04582697820216 | M820-S (M-300) |
| 04582697820209 | M820-C |
| 04582697820193 | M820-SM |
| 04582697820186 | M830-S |
| 04582697820179 | M820-S (M-200) |
| 04582697820162 | M1030-R |
| 04582697820155 | M0830-R |
| 04582697820148 | M0820-R |
| 04582697820131 | 10x 30 |
| 04582697820124 | 10x 20 |
| 04582697820117 | 8x 30 |
| 04582697820100 | 8x 20 |
| 04582697820094 | 7x 25 |
| 04582697820087 | 6x 16 'E' |
| 04582697820070 | 6x 16 'W' |
| 04582697820063 | 3.8x 11 |
| 04582697820056 | 4x 12 |
| 04582697820049 | 4x 10 |
| 04582697820032 | 3x 9 |
| 04582697820025 | 2.75x 8 |
| 04582697820018 | 2x 8 |