PreludeSYNC™ SDRB-REG-LT/A

GUDID 20884450525214

Merit Medical Systems, Inc.

Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external
Primary Device ID20884450525214
NIH Device Record Key5c2f420f-fe42-4fa3-8eec-a04d9a79426b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreludeSYNC™
Version Model Number10884450525217
Catalog NumberSDRB-REG-LT/A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450525210 [Unit of Use]
GS110884450525217 [Primary]
GS120884450525214 [Package]
Contains: 10884450525217
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCCLAMP, VASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

On-Brand Devices [PreludeSYNC™]

2088445041149410884450411497
2088445041151710884450411510
2088445041119710884450411190
1088445044520110884450445201
2088445052557310884450525576
2088445052521410884450525217

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.