Medical Imaging Solutions Intl.

GUDID 10850014500211

2-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes UM

MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY

Angiographic syringe
Primary Device ID10850014500211
NIH Device Record Key41dee30e-d7bc-49ad-8fc3-62f77da347d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical Imaging Solutions Intl.
Version Model Number400109
Company DUNS005179271
Company NameMEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY
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 Datetrue
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
GS100850014500214 [Primary]
GS110850014500211 [Package]
Contains: 00850014500214
Package: case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


[10850014500211]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-25
Device Publish Date2021-01-15

On-Brand Devices [Medical Imaging Solutions Intl.]

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108500145002041-200ml syringe with 1-60" coiled tubing and 1 large spike UM
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108500145000682-65ml syringes, 1-96" T coiled tubing, 1 large spike, 1 small spike YM
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108500145000441-200ml syringe, 1-60" coiled tubing, 1 fill straw YM
108500145000371-200ml syringe, 1-60" coiled tubing, 1 fill straw UM
108500145000201-150ml syringe, 1 fill straw YM
108500145000131-150ml syringe, 1 fill straw UM

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