Identity
- Trade Name
- Prelude® FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Model / Reference
- 10884450330644 FDA UDI
Identifiers
- Catalog Number
- PSI-7F-23MT/C FDA UDI
- Primary DI / UDI-DI
- 10884450330644 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Vascular catheter introduction set, nonimplantable
Prelude [DEVICE NAME] is a single-use, non-implantable vascular catheter introduction set designed for percutaneous catheterization. It features a non-steerable introducer sheath with an inner obturator/dilator and optional access devices such as guidewires, introducer needles, and haemostatic valves to control blood loss.
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 76217252-3697-4001-b297-4ed1b64bb740 34 fields · synced Jul 31, 2026