Identity
- Trade Name
- GENDRON FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Supernal Bed Rail FDA UDI
- Model / Reference
- X-HR-VR-2 FDA UDI
- Description
- Supernal Bed Rail FDA UDI
Identifiers
- Primary DI / UDI-DI
- M368XHRVR21 FDA UDI
- FDA Product Code
- QTC FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
Yes
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: Bedrail
Gendron by GF Health Products, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bedrail.
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- MERITS — MERITS HEALTH PRODUCTS., INC. · Class I
- INVACARE® ASSIST BAR — Invacare Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Composite Swing Rail — Dynarex Corp. · Class I
- Expansion Kit for D300 — Dynarex Corp. · 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
- GF Health Products, Inc
Sources (1)
- FDA UDI 9134501d-3bf7-4a30-b3d7-efc371ad6e83 34 fields · synced May 30, 2026