Identity
- Trade Name
- FusionMAX FDA UDI
- Generic Name
- Medical device rail FDA UDI
- Device Name
- Accessory Rail- moveable side rail for surgical table. Adjustable to full length of table by use of peg system. Designed for to support and secure surgical table attachments FDA UDI
- Model / Reference
- 33501-11-000 FDA UDI
- Description
- Accessory Rail- moveable side rail for surgical table. Adjustable to full length of table by use of peg system. Designed for to support and secure surgical table attachments FDA UDI
Identifiers
- Catalog Number
- 33501-11-000 FDA UDI
- Primary DI / UDI-DI
- 00840343716707 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Medical device rail 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
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: Medical device rail
FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device rail.
- TEIRSTEINEDGE — TELEFLEX INCORPORATED · Class I
- ANGIOASSIST — TELEFLEX INCORPORATED · Class I
- ALLEN — HILL-ROM, INC. · Class I
- Hillrom™ — Baxter Medical Systems GmbH + Co. KG · Class II
- INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
- Wall rail — Reison Medical AB · Class I
- FusionMAX — SURGIX MEDICAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgix Medical Llc
Sources (1)
- FDA UDI 031fdd58-668b-41e6-a0d5-250297fb769d 35 fields · synced May 30, 2026