Identity
- Trade Name
- Prelude EASE™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 10884450144647 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884450144647 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Vascular dilator, single-use
For the Prelude EASE device, Merit Medical Systems, Inc. offers a high-quality, sterile vascular dilator designed for safe and effective insertion into blood vessels. Its Guide Wire Diameter of 0.021 inches, Sheath Length of 23 centimeters, and Needle Gauge of 22G make it an ideal choice for various medical procedures.
Similar devices
Also classified as Vascular dilator, single-use.
- MICRO-STICK SET — JET MEDICAL, INC. · Class II
- TightRail™ — Spectranetics Corporation · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — MEDICAL COMPONENTS INC · Class II
- MICRO-STICK SETMICRO-STICK SET — MEDICAL COMPONENTS INC · Class II
- Broadway System — Stryker Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI c6bdebcd-ec60-40b4-8c78-dc11e5cd1b9e 33 fields · synced Jul 19, 2026