Disposable High Pressure Syringe

GUDID 06970286900452

Union Medical Shenzhen Co.,LTD.

Angiographic syringe
Primary Device ID06970286900452
NIH Device Record Key0d1c6c57-3e19-4a82-965c-7a9bddac9ba0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable High Pressure Syringe
Version Model NumberSEZ103
Company DUNS544445008
Company NameUnion Medical Shenzhen Co.,LTD.
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970286900452 [Package]
Contains: 06970286900513
Package: [20 Units]
In Commercial Distribution
GS106970286900513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-28
Device Publish Date2018-12-26

On-Brand Devices [Disposable High Pressure Syringe]

06970286900438SLF302
06970286900483SEZ301
06970286900407SLF108
06970286900391SLF107
06970286900476SEZ109
06970286900469SEZ108
06970286900452SEZ103
06970286900384SLF103
06970286900445SEZ101
06970286900421SLF301
06970286900414SLF202
06970286900360SLF102
06970286900353SLF101
06970286900377SMR302
06970286900339SMR301
06970286900322SMR201
06970286900315SMR101

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