Elite HV Transitionless Hemostasis Valve Introducer Kit CLI-121-06

GUDID 20841268103607

Elite HV Transitionless Hemostasis Valve Introducer Kit

GALT MEDICAL CORP.

Haemostasis valve
Primary Device ID20841268103607
NIH Device Record Key75bb9eba-2ed3-48eb-ac0b-fad8140b44fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite HV Transitionless Hemostasis Valve Introducer Kit
Version Model NumberCLI-121-06
Catalog NumberCLI-121-06
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 Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100841268103603 [Primary]
GS110841268103600 [Package]
Contains: 00841268103603
Package: Shelf Box [10 Units]
In Commercial Distribution
GS120841268103607 [Package]
Contains: 10841268103600
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

[20841268103607]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-05
Device Publish Date2018-03-01

On-Brand Devices [Elite HV Transitionless Hemostasis Valve Introducer Kit]

20841268108893Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268108886Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268108879Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268108862Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103959Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103942Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103935Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103928Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103911Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103904Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103898Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103881Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103874Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103867Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103850Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103843Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103836Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103829Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103812Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103805Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103799Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103782Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103775Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103768Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103751Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103744Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103737Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103720Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103713Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103706Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103690Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103683Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103676Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103669Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103652Elite HV Transitionless Hemostasis Valve Introducer Kits
20841268103645Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103638Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103621Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103614Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103607Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103591Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103584Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103577Elite HV Transitionless Hemostasis Valve Introducer Kit
20841268103560Elite HV Transitionless Hemostasis Valve Introducer Kit
10841268109022Elite HV Transitionless Hemostasis Valve Introducer Kit
10841268109015Elite HV Transitionless Hemostasis Valve Introducer Kit
10841268109008Elite HV Transitionless Hemostasis Valve Introducer Kit
10841268108995Elite HV Transitionless Hemostasis Valve Introducer Kit

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