Identity
- Trade Name
- Personalized PseudoPatient™ PV FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- Personalized PseudoPatient™ PV IC FDA UDI
- Model / Reference
- PIC-02PV FDA UDI
- Description
- Personalized PseudoPatient™ PV IC FDA UDI
Identifiers
- Catalog Number
- PIC-02PV FDA UDI
- Primary DI / UDI-DI
- 00860001523201 FDA UDI
- 510(k) Number
- K180697 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV by Rtsafe, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180697 also covers:
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
- Rtsafe, Inc.
Sources (1)
- FDA UDI bb1718de-dbe6-4488-a65b-15dfec5d4de4 37 fields · synced Jun 8, 2026