Identity
- Trade Name
- Prelude EASE™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Model / Reference
- 10884450289423 FDA UDI
Identifiers
- Catalog Number
- PHR7F11018SC/C FDA UDI
- Primary DI / UDI-DI
- 10884450289423 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
Prelude EASE is a sterile, hand-held surgical instrument designed for insertion into blood vessels to unblock or enlarge the internal diameter during surgical interventions. It is available in various sizes and flexibilities, typically made of metal or plastic materials.
Similar devices
Also classified as Vascular dilator, single-use.
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- 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 |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 1d4ffeec-90b5-4bc3-95a0-68d86aa1f662 34 fields · synced Jul 9, 2026