GelPOINT V-Path

GUDID 10607915138667

Transvaginal Access Platform

APPLIED MEDICAL RESOURCES CORPORATION

Radial surgical retractor seal cap Radial surgical retractor seal cap
Primary Device ID10607915138667
NIH Device Record Key1c95776b-b188-4b85-a5db-c3d092c17ec6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelPOINT V-Path
Version Model NumberC2A12
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100607915138660 [Primary]
GS110607915138667 [Package]
Contains: 00607915138660
Package: [1 Units]
In Commercial Distribution

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-25
Device Publish Date2019-09-17

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10607915145337Transvaginal Access Platform with Insufflation Stabilization System
10607915145320Transvaginal Access Platform with Insufflation Stabilization System
10607915145313Transvaginal Access Platform with Insufflation Stabilization System

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