FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoropter Arm
DI: 05907642694817
·
Model: PA-3000
·
MDT SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoropter Arm
- Primary DI
- 05907642694817
- Version / Model
- PA-3000
- Company Name
- MDT SP Z O O
- Labeler DUNS
- 366126408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-15
- Public Version
- 1
- Public Version Date
- 2025-07-23
- Public Version Status
- New
- Public Device Record Key
- d45e2fad-72dc-49cb-93b2-0b20cce97ca0
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 |
|---|---|---|---|---|
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | Ophthalmic | 886.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61434 | Portable active medical device mount | A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05907642694817 | GS1 |