Flexible Overtube

GUDID 04545499070098

Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

SUMITOMO BAKELITE COMPANY LIMITED

Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use Endoscopic overtube, single-use
Primary Device ID04545499070098
NIH Device Record Keycc9e2b9a-a53e-4d78-92a7-72be66e976f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Overtube
Version Model NumberMD-48719
Company DUNS690551106
Company NameSUMITOMO BAKELITE COMPANY LIMITED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter16 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Lumen/Inner Diameter16 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Lumen/Inner Diameter16 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Lumen/Inner Diameter16 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Lumen/Inner Diameter16 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter
Length205 Millimeter
Outer Diameter19 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104545499070098 [Primary]
GS124545499070092 [Package]
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEDEndoscopic Access Overtube, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

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04545499070098 - Flexible Overtube2019-10-01Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
04545499070098 - Flexible Overtube2019-10-01 Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for end
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