FDA UDI
In Commercial Distribution
🇺🇸 United States
WALL TRANSFORMER EN 200-1
DI: 04053755199686
·
Model: 000
·
Heine Optotechnik GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WALL TRANSFORMER EN 200-1
- Primary DI
- 04053755199686
- Version / Model
- 000
- Catalog Number
- X-095.12.252
- 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
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- 7c4334c5-8830-4cf1-b888-91d7727cb339
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HJM | Transilluminator, Ac-Powered | Ophthalmic | 886.1945 | 2 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | 886.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16933 | Constant-voltage transformer | A device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053755199686 | GS1 |
Customer Contacts
- Phone
- +1 (603) 742-7103
- [email protected]