Barbell Loop Ostomy Device BAR-2

GUDID 00860002701325

Loop Ostomy Device, Small (2-inch rod).

TOOLS FOR SURGERY, LLC

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Primary Device ID00860002701325
NIH Device Record Key61ff0329-dfe1-4ef3-927f-41d7997030f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarbell Loop Ostomy Device
Version Model NumberBAR-2
Catalog NumberBAR-2
Company DUNS841842441
Company NameTOOLS FOR SURGERY, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch
Length2 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002701325 [Primary]

FDA Product Code

EZPRod, Colostomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-25
Device Publish Date2023-07-17

On-Brand Devices [Barbell Loop Ostomy Device]

00860002701356Loop Ostomy Device, Large (4-inch rod).
00860002701349Loop Ostomy Device, Medium (3-inch rod).
00860002701325Loop Ostomy Device, Small (2-inch rod).

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