HeartSpan® FND-025-03/A

GUDID 00884450451731

Merit Medical Systems, Inc.

Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use Cardiac transseptal needle, single-use
Primary Device ID00884450451731
NIH Device Record Keya061a900-c2b5-4ca3-b87f-fd69ea4c16c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartSpan®
Version Model Number00884450451731
Catalog NumberFND-025-03/A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]
GS100884450451731 [Primary]

FDA Product Code

DRCTrocar
DRCTrocar
DRCTrocar
DRCTrocar
DRCTrocar
DRCTrocar
DRCTrocar
DRCTrocar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [HeartSpan®]

1088445048972400884450489727
1088445045171400884450451717
0088445045176200884450451762
0088445045175500884450451755
0088445045174800884450451748
0088445045173100884450451731
0088445045172400884450451724

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