FDA UDI
In Commercial Distribution
🇺🇸 United States
PalmScan PM2000
DI: 00853569007115
·
Model: PM2000
·
Micro Medical Devices, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PalmScan PM2000
- Primary DI
- 00853569007115
- Version / Model
- PM2000
- Catalog Number
- 900-0011-12
- Company Name
- Micro Medical Devices, Inc.
- Labeler DUNS
- 146767400
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 1
- Public Version Date
- 2023-08-24
- Public Version Status
- New
- Public Device Record Key
- 5d0dc394-95a8-4605-b1a9-235d84f8a105
- Distribution End Date
- 2030-03-01
Device Description
Advanced VR Pupilometer PUPILLOGRAPH
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 |
|---|---|---|---|---|
| HRI | Pupillograph | Ophthalmic | 886.1690 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13235 | Pupillograph | A mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853569007115 | GS1 |
Customer Contacts
- Phone
- 8182223310
- [email protected]