Identity
- Trade Name
- SchureMed FDA UDI
- Generic Name
- Head/neck procedure positioner FDA UDI
- Device Name
- HD Double Ball Joint Assembly with Malleable Insert FDA UDI
- Model / Reference
- 790-0063-M FDA UDI
- Description
- HD Double Ball Joint Assembly with Malleable Insert FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810014603858 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Head/neck procedure positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Head/neck procedure positioner
SchureMed by Schuerch Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AADCO — AADCO MEDICAL, INC. · Class I
- Orfit Industries — Orfit Industries NV · Class II
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
- Schuerch Corporation
Sources (1)
- FDA UDI e6e69d5b-bb29-4c5e-9e4a-8255b71bb746 34 fields · synced Jun 8, 2026