Identity
- Trade Name
- Prelude SNAP 165™ FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Model / Reference
- 10884450484491 FDA UDI
Identifiers
- Catalog Number
- PLS165/A FDA UDI
- Primary DI / UDI-DI
- 10884450484491 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-vascular catheter introduction set
The Prelude SNAP 165 is a single-use non-vascular catheter introduction set designed for sterile and safe insertion of invasive access devices into the body. This device is intended for use in medical procedures, particularly in the fields of general surgery and urology.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 32638fe0-181b-4d07-898f-921b9bf8f104 33 fields · synced Jul 14, 2026