VSI De-Clot Micro-HV Introducer Kit CLI-623-05

GUDID 20841268106431

VSI De-Clot Micro-HV Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID20841268106431
NIH Device Record Keyc59b4f87-be0b-496c-8f19-4f824440e6e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSI De-Clot Micro-HV Introducer Kit
Version Model NumberCLI-623-05
Catalog NumberCLI-623-05
Company DUNS943156836
Company NameGALT MEDICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-639-2800
Emailcustomerservice@galtneedletech.com

Device Dimensions

Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268106437 [Primary]
GS110841268106434 [Package]
Contains: 00841268106437
Package: Shelf Box [5 Units]
In Commercial Distribution
GS120841268106431 [Package]
Contains: 10841268106434
Package: Shipper Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841268106431]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-05-28

On-Brand Devices [VSI De-Clot Micro-HV Introducer Kit]

20841268106455VSI De-Clot Micro-HV Introducer Kit
20841268106448VSI De-Clot Micro-HV Introducer Kit
20841268106431VSI De-Clot Micro-HV Introducer Kit
20841268106424VSI De-Clot Micro-HV Introducer Kit
20841268106417VSI De-Clot Micro-HV Introducer Kit
20841268106400VSI De-Clot Micro-HV Introducer Kit

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