GelPOINT V-Path

GUDID 10607915145320

Transvaginal Access Platform with Insufflation Stabilization System

APPLIED MEDICAL RESOURCES CORPORATION

Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap Radial surgical retractor seal cap
Primary Device ID10607915145320
NIH Device Record Keyfc596b47-89d7-4e0f-881f-b9382737efe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGelPOINT V-Path
Version Model NumberC2B12
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
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
Phone1-949-713-8300
Emailcontact@appliedmedical.com
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110607915145320 [Primary]

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 Date2023-03-27
Device Publish Date2023-03-17

On-Brand Devices [GelPOINT V-Path ]

10607915138667Transvaginal Access Platform
10607915138490Transvaginal Access Platform
10607915138483Transvaginal Access Platform
00607915145613Transvaginal Access Platform
10607915146693Transvaginal Access Platform with Insufflation Stabilization System
10607915145368Transvaginal Access Platform with Total vNOTES Access System
10607915145351Transvaginal Access Platform with Total vNOTES Access System
10607915145344Transvaginal Access Platform with Total vNOTES Access System
10607915145337Transvaginal Access Platform with Insufflation Stabilization System
10607915145320Transvaginal Access Platform with Insufflation Stabilization System
10607915145313Transvaginal Access Platform with Insufflation Stabilization System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.