FDA.report

Prelude® PRO

Primary DI
20884450076730
Brand
Prelude® PRO
Company
Merit Medical Systems, Inc.
Model
G
Catalog number
PRO-8F-11-038MT
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884450076730PackageGS14In Commercial Distribution
10884450076733PrimaryGS10
00884450076736Unit of UseGS10

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
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10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
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10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

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10884450441784SteadySheath®Merit Medical Systems, Inc.DRE2026-03-21
10884450441616Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441746Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.DRE2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.DRE2026-03-06
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.DRE2026-03-05
20884450707795Prelude®Merit Medical Systems, Inc.DRE2026-02-14
08033178019545PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019552PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019576PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019583PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019590PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
20884450706798Prelude®Merit Medical Systems, Inc.DRE2026-01-16
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10884450847333Merit MAK™Merit Medical Systems, Inc.DRE2025-12-05
10884521811188RitusMozarc Medical US LLCDRE2025-11-27
10884450587185Merit PAK™Merit Medical Systems, Inc.DRE2025-09-05
20884450707177Prelude ACT™Merit Medical Systems, Inc.DRE2025-09-04
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10884450847265Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-05
10884450847340Merit S-MAK™Merit Medical Systems, Inc.DRE2025-07-16
00763000925093FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.DRE2025-07-13