Identity
- Trade Name
- Schon FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- Schon Insertion Tray Blunt Tip Trocar (without Catheter) FDA UDI
- Model / Reference
- 10802304 FDA UDI
- Description
- Schon Insertion Tray Blunt Tip Trocar (without Catheter) FDA UDI
Identifiers
- Primary DI / UDI-DI
- H787108023040 FDA UDI
- FDA Product Code
- MSD FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDI
Category: Double-lumen haemodialysis catheter, implantable
Schon by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Double-lumen haemodialysis catheter, implantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
- Palindrome — Mozarc Medical US LLC · Class II
- HEMO-FLOW® — MEDICAL COMPONENTS INC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA UDI fe746749-1ec6-40ed-ac99-140fd7f7326e 36 fields · synced Jun 8, 2026