Identity
- Trade Name
- Merge Eye Station FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- 11.6.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842000100140 FDA UDI
- 510(k) Number
- K913929 FDA UDI
- FDA Product Code
- NFJ FDA UDIHKI FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI886.1120 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Merge Eye Station by Merge Healthcare Solutions Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Merge Healthcare Solutions Inc.
Sources (1)
- FDA UDI 29dfacc9-9675-439a-b4ba-5f7607922360 34 fields · synced May 30, 2026