Identity
- Trade Name
- Head Wedge™ FDA UDI
- Generic Name
- Head/neck immobilizer, single-use FDA UDI
- Device Name
- Cervical Immobilization Device FDA UDI
- Model / Reference
- 000264034 FDA UDI
- Description
- Cervical Immobilization Device FDA UDI
Identifiers
- Catalog Number
- 000264034 FDA UDI
- Primary DI / UDI-DI
- 05707480024438 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Head/neck immobilizer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Head/neck immobilizer, single-use
Head Wedge™ by Ambu A/S — 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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- SchureMed — SCHUERCH CORPORATION · Class I
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- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · 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
- Ambu A/S
Sources (1)
- FDA UDI 0eaabc78-f88e-49ca-b6cd-3a0216463261 36 fields · synced May 30, 2026