6.5mm Cartridge

GUDID 00810275013014

Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web

ENDOGASTRIC SOLUTIONS, INC.

Endoscopic suturing unit, single-use
Primary Device ID00810275013014
NIH Device Record Key5145af5f-8c7a-4ae0-9119-d73868bfbefe
Commercial Distribution StatusIn Commercial Distribution
Brand Name6.5mm Cartridge
Version Model NumberR2165
Company DUNS143602659
Company NameENDOGASTRIC SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Customer Support Contacts

Phone425-307-9269
Emailcustomerservice@endogastricsolutions.com
Phone425-307-9269
Emailcustomerservice@endogastricsolutions.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100810275013014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

Devices Manufactured by ENDOGASTRIC SOLUTIONS, INC.

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