Silicone Tubing, Penrose Drain

GUDID 10684995520087

1/2 in. x 18 in. Length

BENTEC MEDICAL OPCO, LLC

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Primary Device ID10684995520087
NIH Device Record Keycf271890-683d-4d53-8d60-ea6c58b26787
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Tubing, Penrose Drain
Version Model NumberGR203
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
GS100684995520080 [Primary]
GS110684995520087 [Package]
Contains: 00684995520080
Package: [25 Units]
In Commercial Distribution

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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