Medical Imaging Solutions Intl.

GUDID 10850014500075

1-65ml & 1-115 ml syringe, 1-96" T coiled tubing, 1 large spike, 1 small spike UM

MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANY

Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe
Primary Device ID10850014500075
NIH Device Record Key74bc5efd-7e02-49e9-be7d-44f76011eba9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical Imaging Solutions Intl.
Version Model Number100302T
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
GS100850014500078 [Primary]
GS110850014500075 [Package]
Contains: 00850014500078
Package: case [50 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

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

Ethylene Oxide

[10850014500075]

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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108500145003582-100ml syringes, 1-96" Y coiled tubing with dual check valves, 1 large spike, 1 small spike YM
108500145003412-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes YM
108500145003341-200ml syringe with 1-60" coiled tubing and 1 large spike YM
108500145003272-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 fill straws YM
108500145003101-200ml syringe, 1-60" coiled tubing, 1 fill straw YM
108500145003031-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike YM
108500145002972-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike, 1 small spike YM
108500145002801-150ml syringe, 1 fill straw YM
108500145002732-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes YM
108500145002661-200ml syringe with 1-60" coiled tubing and 1 large spike YM
108500145002592-200ml syringes, 1-60" Y coiled tubing with dual check valves, 2 fill straws YM
108500145002421-200ml syringe, 1-60" Y coiled tubing with dual check valves, 1 fill straw YM
108500145002351-200ml syringe, (short w/ integrated threads) 1-60" coiled tubing, 1 fill straw YM
108500145002282-100ml syringes, 1-96" Y coiled tubing with dual check valves, 1 large spike, 1 small spike UM
108500145002112-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes UM
108500145002041-200ml syringe with 1-60" coiled tubing and 1 large spike UM
108500145001982-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 fill straws UM
108500145001811-200ml syringe, 1-60" coiled tubing, 1 fill straw UM
108500145001741-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike UM
108500145001672-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike, 1 small spike UM
108500145001501-150ml syringe, 1 fill straw UM
108500145001432-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes UM
108500145001361-200ml syringe with 1-60" coiled tubing and 1 large spike UM
108500145001292-200ml syringes, 1-60" Y coiled tubing with dual check valves, 2 fill straws UM
108500145001121-200ml syringe, 1-60" Y coiled tubing with dual check valves, 1 fill straw UM
108500145001051-200ml syringe, 1-60" coiled tubing, 1 fill straw YM
208500145000961-200ml syringe, 1-60" coiled tubing, 1 fill straw UM
108500145000821-65ml & 1-115 ml syringe, 1-96" T coiled tubing, 1 large spike, 1 small spike YM
108500145000751-65ml & 1-115 ml syringe, 1-96" T coiled tubing, 1 large spike, 1 small spike UM
108500145000682-65ml syringes, 1-96" T coiled tubing, 1 large spike, 1 small spike YM
108500145000512-65ml syringes, 1-96" T coiled tubing, 1 large spike, 1 small spike UM
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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