5cc Graft Tube Steel

GUDID 00858406007105

SURGENTEC, LLC

Syringe dose safety regulator
Primary Device ID00858406007105
NIH Device Record Key58e88c2d-95dc-4604-b763-d8d08111bb00
Commercial Distribution StatusIn Commercial Distribution
Brand Name5cc Graft Tube Steel
Version Model NumberGG-GTS-05
Company DUNS004095409
Company NameSURGENTEC, LLC
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
GS100858406007105 [Primary]

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 Date2025-02-20
Device Publish Date2025-02-12

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