Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Heavy Duty Operating Table Bed Rail, 1/4 inch x 12 inch x 48 inch solid stainless steel plate/rail with welded 1-1/4 inch x 1/4 inch stainless steel legs extending 6 inches. The rail will be rounded on all sides. FDA UDI
- Model / Reference
- 3315-4812 FDA UDI
- Description
- Heavy Duty Operating Table Bed Rail, 1/4 inch x 12 inch x 48 inch solid stainless steel plate/rail with welded 1-1/4 inch x 1/4 inch stainless steel legs extending 6 inches. The rail will be rounded on all sides. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G453331548120 FDA UDI
- FDA Product Code
- GDC FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
No
FDA UDI
Category: Bedrail
Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bedrail.
- Homecare Half Length Bed Rail Cross Bar Mount — Dynarex Corp. · Class I
- ProBasics — COMPASS HEALTH BRANDS CORP. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI 4f966215-83f2-4242-82ed-a4ebecb1c7c9 33 fields · synced Jun 8, 2026