Identity
- Trade Name
- Spencer FDA UDI
- Generic Name
- Head/neck immobilizer, reusable FDA UDI
- Model / Reference
- SH00260A PEDI FIX PAEDIATRIC HEADIMMOBILISER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057711231249 FDA UDI
- FDA Product Code
- IQK FDA UDI
- GMDN Term
- Head/neck immobilizer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Head/neck immobilizer, reusable
Spencer by Spencer Italia Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Head/neck immobilizer, reusable.
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- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- Trulife — TRULIFE, INC. · Class I
- Trulife — TRULIFE, INC. · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, 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
- Spencer Italia Srl
Sources (1)
- FDA UDI bf5bb0ca-2651-4b8b-81dc-92d2a36bed3c 32 fields · synced Jun 1, 2026