Prelude SNAP™ 10884450468064
by Merit Medical Systems, Inc.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Overview
Prelude SNAP is a non-implantable vascular catheter introduction set designed to provide percutaneous vascular access for the introduction of a catheter into the vascular system. This single-use device includes a non-steerable introducer sheath with an inner obturator/dilator, and may be accompanied by additional access devices such as a guidewire, introducer needle, syringe, or haemostatic valve. The device is intended for use in cardiology and critical care settings where vascular access is required.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884450468064 | Date30 Oct 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Prelude SNAP™
- Generic Name
- Vascular catheter introduction set, nonimplantable
- Model / Ref / Catalog
- 10884450468064, PLS-1011/A
- Primary DI / UDI-DI
- 10884450468064
- FDA Product Code
- DYB
- GMDN Term
- Vascular catheter introduction set, nonimplantable
- Device Class
- Class II
- Regulation Number
- 870.1340
- GUDID distribution status
- In Commercial Distribution
Other devices from Merit Medical Systems, Inc.
Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No