Identity
- Trade Name
- Saratoga Cervical Brace FDA UDI
- Generic Name
- Cervical spine collar, reusable FDA UDI
- Model / Reference
- MPE01010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B064MPE010101 FDA UDI
- FDA Product Code
- IQK FDA UDI
- GMDN Term
- Cervical spine collar, 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
Yes
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
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: Cervical spine collar, reusable
Saratoga Cervical Brace by Xenco Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cervical spine collar, reusable.
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- Cervical Collar — Dynarex Corp. · Class I
- MedSource Extrication Collar — MEDSOURCE INTERNATIONAL LLC · 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
- Xenco Medical Llc
Sources (1)
- FDA UDI d3016a81-54bc-415a-9a8c-d2956ac741e5 32 fields · synced May 31, 2026