Identity
- Trade Name
- PalmScan K2000 FDA UDI
- Generic Name
- Keratoscope, powered FDA UDI
- Device Name
- Portable Keratometer TOPOGRAPHER, CORNEAL, BATTERY POWERED FDA UDI
- Model / Reference
- K2000 FDA UDI
- Description
- Portable Keratometer TOPOGRAPHER, CORNEAL, BATTERY POWERED FDA UDI
Identifiers
- Catalog Number
- 900-0008-01 FDA UDI
- Primary DI / UDI-DI
- 00853569007047 FDA UDI
- FDA Product Code
- NOG FDA UDI
- GMDN Term
- Keratoscope, powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Keratoscope, powered
PalmScan K2000 by Micro Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Keratoscope, powered.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micro Medical Devices, Inc.
Sources (1)
- FDA UDI 361a2977-c91e-4a18-8034-7f28d68b402e 36 fields · synced May 30, 2026