EpiRite Syringe, w/o Needle, 1cc, Luer Slip, 10/100/Cs

GUDID 00616784698526

DYNAREX CORPORATION

Metered-delivery hypodermic syringe
Primary Device ID00616784698526
NIH Device Record Key45bd386e-d44e-415c-a643-3a7e9a5adc3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpiRite Syringe, w/o Needle, 1cc, Luer Slip, 10/100/Cs
Version Model Number6985
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784698526 [Primary]
GS100616784698533 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS100810180840194 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-16
Device Publish Date2018-07-16

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