Micro-Access Elite HV Introducer Set CLI-101-15

GUDID 20841268103300

Micro-Access Elite HV Introducer Set

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID20841268103300
NIH Device Record Keyd37a9c10-7404-4060-b1a3-2a1d1af54d48
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro-Access Elite HV Introducer Set
Version Model NumberCLI-101-15
Catalog NumberCLI-101-15
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
GS100841268103306 [Primary]
GS110841268103303 [Package]
Contains: 00841268103306
Package: Shelf Box [10 Units]
In Commercial Distribution
GS120841268103300 [Package]
Contains: 10841268103303
Package: Shipper Box [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841268103300]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2018-02-23

On-Brand Devices [Micro-Access Elite HV Introducer Set]

20841268108756Micro-Access Elite HV Introducer Set
20841268108749Micro-Access Elite HV Introducer Set
20841268106851Micro-Access Elite HV Introducer Set
20841268103553Micro-Access Elite HV Introducer Set
20841268103546Micro-Access Elite HV Introducer Set
20841268103539Micro-Access Elite HV Introducer Set
20841268103522Micro-Access Elite HV Introducer Set
20841268103515Micro-Access Elite HV Introducer Set
20841268103508Micro-Access Elite HV Introducer Set
20841268103492Micro-Access Elite HV Introducer Set
20841268103485Micro-Access Elite HV Introducer Set
20841268103478Micro-Access Elite HV Introducer Set
20841268103461Micro-Access Elite HV Introducer Set
20841268103454Micro-Access Elite HV Introducer Set
20841268103324Micro-Access Elite HV Introducer Set
20841268103317Micro-Access Elite HV Introducer Set
20841268103300Micro-Access Elite HV Introducer Set
20841268103294Micro-Access Elite HV Introducer Set
20841268103287Micro-Access Elite HV Introducer Set
20841268103270Micro-Access Elite HV Introducer Set
20841268103263Micro-Access Elite HV Introducer Set
20841268103256Micro-Access Elite HV Introducer Set
20841268103249Micro-Access Elite HV Introducer Set
20841268103232Micro-Access Elite HV Introducer Set
20841268103225Micro-Access Elite HV Introducer Set
20841268103218Micro-Access Elite HV Introducer Set
20841268103201Micro-Access Elite HV Introducer Set
20841268103195Micro-Access Elite HV Introducer Set
20841268103188Micro-Access Elite HV Introducer Set
20841268103171Micro-Access Elite HV Introducer Set

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