FDA UDI
In Commercial Distribution
🇺🇸 United States
MedCenter 5000 wall mounted Set F.O./E56, US
DI: 04030155013415
·
Model: 02.85020.002
·
Kirchner & Wilhelm GmbH + Co KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MedCenter 5000 wall mounted Set F.O./E56, US
- Primary DI
- 04030155013415
- Version / Model
- 02.85020.002
- Catalog Number
- 02.85020.002
- Company Name
- Kirchner & Wilhelm GmbH + Co KG
- Labeler DUNS
- 315480269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-04
- Public Version
- 1
- Public Version Date
- 2023-09-12
- Public Version Status
- New
- Public Device Record Key
- 7799622b-2a9f-42b8-b8af-8dcd65de9ac3
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
- 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 |
|---|---|---|---|---|
| HPI | Aid, Vision, Optical, Ac-Powered | Ophthalmic | 886.5915 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04030155013415 | GS1 | ||||
| Direct Marking | 04030155013378 | GS1 |