Silicone Tubing, Radiopaque

GUDID 00684995540064

8 Fr. x 100 cm

BENTEC MEDICAL OPCO, LLC

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Primary Device ID00684995540064
NIH Device Record Key91429b3f-79d9-4eb8-8f5a-376f9453c961
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Tubing, Radiopaque
Version Model NumberGS75160-48
Company DUNS080524654
Company NameBENTEC MEDICAL OPCO, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100684995540064 [Primary]

FDA Product Code

GBXCatheter, Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

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