FDA UDI
In Commercial Distribution
🇺🇸 United States
PalmScan K2000
DI: 00853569007047
·
Model: K2000
·
Micro Medical Devices, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PalmScan K2000
- Primary DI
- 00853569007047
- Version / Model
- K2000
- Catalog Number
- 900-0008-01
- 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
- 361a2977-c91e-4a18-8034-7f28d68b402e
- Distribution End Date
- 2030-01-01
Device Description
Portable Keratometer TOPOGRAPHER, CORNEAL, BATTERY POWERED
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 |
|---|---|---|---|---|
| NOG | Topographer, Corneal, Battery Powered | Ophthalmic | 886.1350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16347 | Keratoscope, powered | An electrically-powered ophthalmic device intended for qualitative assessment of the curvature of the anterior surface of the cornea, typically to detect astigmatism during ophthalmic surgery; it is not a keratometer. It may be designed as a hand-held instrument or to be mounted on a device (e.g., on an ophthalmic surgical microscope) and emits concentric rings of light onto the corneal surface (similar to a Placido disk) whereby the distorted reflection of the light rings on the cornea of the patient is indicative of astigmatism. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853569007047 | GS1 |
Customer Contacts
- Phone
- 8182223310
- [email protected]