GelPOINT Path Transanal Access Platform

GUDID 10607915137912

Transanal Access Platform with Insufflation Stabilization Bag

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic multi-instrument access port, single-use
Primary Device ID10607915137912
NIH Device Record Key525bea45-631a-46e7-8275-e8fc66153a98
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelPOINT Path Transanal Access Platform
Version Model NumberCNB10
Company DUNS187129135
Company NameAPPLIED MEDICAL RESOURCES CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com

Device Dimensions

Length4 Centimeter
Length4 Centimeter
Length4 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100607915137915 [Primary]
GS110607915137912 [Package]
Contains: 00607915137915
Package: [1 Units]
In Commercial Distribution

FDA Product Code

FERAnoscope And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-26
Device Publish Date2018-04-03

On-Brand Devices [GelPOINT Path Transanal Access Platform]

10607915137929Transanal Access Platform with Insufflation Stabilization Bag
10607915137912Transanal Access Platform with Insufflation Stabilization Bag
10607915137301Transanal Access Platform with Insufflation Stabilization bag

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