FDA UDI
In Commercial Distribution
🇺🇸 United States
HEINE EN 200® Diagnostic Center
DI: 04053755190652
·
Model: 166
·
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
- HEINE EN 200® Diagnostic Center
- Primary DI
- 04053755190652
- Version / Model
- 166
- Catalog Number
- A-095.12.205
- 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
- 2017-11-03
- Public Version
- 3
- Public Version Date
- 2020-08-19
- Public Version Status
- Update
- Public Device Record Key
- 64c3fb14-387e-49f7-8732-26d347b3d3c0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 60353 | General physical examination set | A collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053755190652 | GS1 |
Customer Contacts
- Phone
- +1(800)643-6275
- [email protected]