FDA UDI
In Commercial Distribution
🇺🇸 United States
K 180 OPHTHALMOSCOPE
DI: 04053755120017
·
Model: 2,5 V
·
Heine Optotechnik GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- K 180 OPHTHALMOSCOPE
- Primary DI
- 04053755120017
- Version / Model
- 2,5 V
- Catalog Number
- C-001.30.206
- Company Name
- Heine Optotechnik GmbH & Co. KG
- Labeler DUNS
- 315274563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 2
- Public Version Date
- 2024-06-28
- Public Version Status
- Update
- Public Device Record Key
- ca672506-4f87-4c42-bc31-f6507dd87752
Device Description
since 2024-05 in LED version: K180 LED ophthalmoscope
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46786 | Direct ophthalmoscope | An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053755120017 | GS1 |
Customer Contacts
- Phone
- +1 (603) 742-7103
- [email protected]