HEINE OMEGA®500
- Primary DI
- 04053755188406
- Brand
- HEINE OMEGA®500
- Company
- Heine Optotechnik GmbH & Co. KG
- Model
- L
- Catalog number
- C-004.33.530
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HLI | Ophthalmoscope, Ac-Powered |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04053755188406 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04053755188406 | 04053755188406 | 4053755188406 |
GMDN Terms
| Term | Definition |
|---|
| Indirect binocular ophthalmoscope, line-powered | A mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage. |
Regulatory Flags
- DUNS number
- 315274563
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00697077003050 | Amico Diagnostic, Inc. | Amico Diagnostic Incorporated | HLI | 2024-09-18 |
| 00697077003043 | DS-UDN-CLFL-DAI | Amico Diagnostic Incorporated | HLI | 2024-07-11 |
| 00697077003029 | NA | Amico Diagnostic Incorporated | HLI | 2024-05-02 |
| 00732094086515 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2023-08-17 |
| 00732094087727 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2023-08-17 |
| 00732094089202 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2023-08-17 |
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| 00732094346947 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-08 |
| 00732094346954 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-08 |
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| 00732094346992 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00732094347005 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00732094347012 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
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| 00732094347142 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00732094348965 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
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| 00732094348989 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00732094348996 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00732094349009 | Welch Allyn, Inc. | WELCH ALLYN, INC. | HLI | 2022-08-05 |
| 00697077002923 | NA | Amico Diagnostic Incorporated | HLI | 2022-02-02 |
| 00697077002930 | NA | Amico Diagnostic Incorporated | HLI | 2022-02-02 |
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