Insulin Syringe

GUDID 00616784695037

DYNAREX CORPORATION

Insulin syringe/needle, basic
Primary Device ID00616784695037
NIH Device Record Key635a1fd0-7ec6-4955-be90-0c1db403360d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsulin Syringe
Version Model Number6950
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count10
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784695006 [Unit of Use]
GS100616784695013 [Primary]
GS100616784695020 [Package]
Contains: 00616784695013
Package: Box [10 Units]
In Commercial Distribution
GS100616784695037 [Package]
Contains: 00616784695020
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Insulin Syringe]

006167846959386959
006167846958396958
006167846957306957
006167846956316956
006167846955326955
006167846954336954
006167846953346953
006167846952356952
006167846951366951
006167846950376950
006167846949316949
006167846948326948
006167846947336947
006167846946346946
006167846945356945
006167846944366944
006167846943376943
006167846942386942
006167846941396941
006167846940306940

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