DEVICE: Prelude® (10884450331207)
Device Identifier (DI) Information
Prelude®
10884450331207
In Commercial Distribution
PSI-4F-11-018/C
Merit Medical Systems, Inc.
10884450331207
In Commercial Distribution
PSI-4F-11-018/C
Merit Medical Systems, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58865 | Vascular catheter introduction set, nonimplantable |
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Needle Gauge (G)-21G |
Device Size Text, specify: Sheath Length (cm)-11 cm (4.3") |
Device Size Text, specify: Sheath French Size (F)-4F |
Device Size Text, specify: Guide Wire Diameter-0.018" (0.46 mm) |
Device Record Status
275fc220-f16e-406c-b60d-324c95a524ee
March 20, 2024
5
January 02, 2018
March 20, 2024
5
January 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884450331204 | 4 | 10884450331207 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00884450331200
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined