Identity
- Trade Name
- SchureMed FDA UDI
- Generic Name
- Head/neck immobilizer, single-use FDA UDI
- Device Name
- Premium Head & Chin Straps FDA UDI
- Model / Reference
- 800-0369 FDA UDI
- Description
- Premium Head & Chin Straps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810014603841 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Head/neck immobilizer, single-use 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Head/neck immobilizer, single-use
SchureMed by Schuerch Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Head/neck immobilizer, single-use.
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- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
- Beach Chair Head and Chin Straps — Aspen Surgical Products, Inc. · Class I
- Head Wedge™ — Ambu A/S · Class I
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 21fa66a9-230f-41eb-8ec0-38b383eea655 34 fields · synced Jun 8, 2026