Specwell
36 catalogue numbers from M820-C, listed by Specwell Corporation, Japan, under Telescope, Hand-Held, Low-Vision. 1 manufacturer in China is registered for this product code.
1manufacturer
36catalogue numbers in this listing
Who Else Makes It
Registered in Anhui.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anhui Yibao Home Textile Co., Ltd. | Hefei | Anhui | Manufacturer | 31 |
Record
| Listed by | Specwell Corporation, Japan |
|---|---|
| FDA product code | HKB |
| Device type | Telescope, Hand-Held, Low-Vision |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5870 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-24 |
| Record revised | 2022-11-09 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M820-C | In distribution | |
| M1030 (30x) | In distribution | |
| M820-S (M-200) | In distribution | |
| M0616 (20x) | In distribution | |
| 7x 25 | In distribution | |
| M0820-R | In distribution | |
| M820-C (25x) | In distribution | |
| 3.8x 11 | In distribution | |
| M0616 (25x) | In distribution | |
| 2x 8 | In distribution | |
| M0412 (12x) | In distribution | |
| 4x 10 | In distribution | |
| M1030-R | In distribution | |
| M0830 (25x) | In distribution | |
| M0820 (35x) | In distribution | |
| 2.75x 8 | In distribution | |
| M1030 (45x) | In distribution | |
| M820-S (M-300) | In distribution | |
| 4x 12 | In distribution | |
| M0820 (25x) | In distribution | |
| M0412 (16x) | In distribution | |
| 10x 30 | In distribution | |
| M820-SM (Pasco) | In distribution | |
| M820-C (35x) | In distribution | |
| M0830-R | In distribution | |
| 6x 16 ‘E’ | In distribution | |
| 3x 9 | In distribution | |
| M0725 (30x) | In distribution | |
| 8x 30 | In distribution | |
| 6x 16 ‘W’ | In distribution | |
| 8x 20 | In distribution | |
| M0725 (IPG) | In distribution | |
| M830-S | In distribution | |
| M820-SM | In distribution | |
| M0830 (40x) | In distribution | |
| 10x 20 | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.