Identity
- Trade Name
- Passive Headrest FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- PH-2500 Passive Headrest FDA UDI
- Model / Reference
- PH-2500-00776 FDA UDI
- Description
- PH-2500 Passive Headrest FDA UDI
Identifiers
- Catalog Number
- PH-2500 FDA UDI
- Primary DI / UDI-DI
- 00873263007761 FDA UDI
- 510(k) Number
- K031885 FDA UDI
- FDA Product Code
- HBL FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4460 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 Unsafe FDA UDI
Passive Headrest by Fhc, 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
- Fhc, Inc.
Sources (1)
- FDA UDI 4bc49535-9e59-4cf2-be57-5c8a1c0676b6 37 fields · synced Jun 6, 2026