00711836

GUDID 10724995216525

The Endoscopic Marker is a 5mL single-use solution designed to endoscopically mark lesions in the gastrointestinal tract.

US Endoscopy

Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink
Primary Device ID10724995216525
NIH Device Record Key906b84cd-0c41-46b1-9630-e891f8dac64c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number00711836
Catalog Number00711836
Company DUNS627879687
Company NameUS Endoscopy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995216528 [Primary]
GS110724995216525 [Package]
Contains: 00724995216528
Package: Box [10 Units]
In Commercial Distribution
GS150724995216523 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NBGMarker, colon

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-07
Device Publish Date2022-01-28

Devices Manufactured by US Endoscopy

00724995227340 - NA2023-11-21 gi400 Electrosurgery Unit Evaluation Kit
00724995199296 - truFreeze2023-07-19 truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting p
20724995221618 - Ascendo2023-07-19 Ascendo Submucosal Lifting Agent
10724995216839 - Torrent2023-05-15 The Torrent irrigation scope connector is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile w
50724995216844 - Torrent2023-05-15 The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as st
50724995220681 - Assurance2023-03-30 The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purp
10724995220690 - Assurance2023-03-30 The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpo
10724995211537 - UroSeal2022-12-06 The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the workin

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