SPECWELL
- Primary DI
- 04582697820155
- Brand
- SPECWELL
- Company
- SPECWELL CORPORATION
- Model
- M0830-R
- Published
- 2022-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Sterile
- true
Product Codes#
| Code | Name |
|---|---|
| HKB | Telescope, Hand-Held, Low-Vision |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HKB | Telescope, Hand-Held, Low-Vision | Ophthalmic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04582697820155 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04582697820155 | 04582697820155 | 4582697820155 |
GMDN Terms#
| Term | Definition |
|---|---|
| Indirect monocular ophthalmoscope | An electrically-powered, hand-held, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s one eye (monocular). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a built-in light (e.g., non-polarized light) directed through the pupil to illuminate the interior of the eyeball, lenses, and filters. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 701065054
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Contains natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04582697820018 | SPECWELL | 2x 8 | 2022-09-24 | |
| 04582697820025 | SPECWELL | 2.75x 8 | 2022-09-24 | |
| 04582697820032 | SPECWELL | 3x 9 | 2022-09-24 | |
| 04582697820049 | SPECWELL | 4x 10 | 2022-09-24 | |
| 04582697820056 | SPECWELL | 4x 12 | 2022-09-24 | |
| 04582697820063 | SPECWELL | 3.8x 11 | 2022-09-24 | |
| 04582697820070 | SPECWELL | 6x 16 'W' | 2022-09-24 | |
| 04582697820087 | SPECWELL | 6x 16 'E' | 2022-09-24 | |
| 04582697820094 | SPECWELL | 7x 25 | 2022-09-24 | |
| 04582697820100 | SPECWELL | 8x 20 | 2022-09-24 | |
| 04582697820117 | SPECWELL | 8x 30 | 2022-09-24 | |
| 04582697820124 | SPECWELL | 10x 20 | 2022-09-24 | |
| 04582697820131 | SPECWELL | 10x 30 | 2022-09-24 | |
| 04582697820148 | SPECWELL | M0820-R | 2022-09-24 | |
| 04582697820162 | SPECWELL | M1030-R | 2022-09-24 | |
| 04582697820209 | SPECWELL | M820-C | 2022-09-24 | |
| 04582697820216 | SPECWELL | M820-S (M-300) | 2022-09-24 | |
| 04582697820179 | SPECWELL | M820-S (M-200) | 2022-09-24 | |
| 04582697820186 | SPECWELL | M830-S | 2022-09-24 | |
| 04582697820193 | SPECWELL | M820-SM | 2022-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04582697820018 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820025 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820032 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820049 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820056 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820063 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820070 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820087 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820094 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820100 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820117 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820124 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820131 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820148 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820162 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820179 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820186 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820193 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820209 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820216 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820223 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820230 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820247 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820254 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820261 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820278 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820285 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820292 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820308 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |
| 04582697820315 | SPECWELL | SPECWELL CORPORATION | HKB | 2022-09-24 |