Restorelle 501440

GUDID 05708932483964

Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - L

Coloplast A/S

Pelvic organ prolapse surgical mesh, synthetic polymer
Primary Device ID05708932483964
NIH Device Record Key802aa5e9-c5db-4f48-b4ba-d21ab50c3a21
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestorelle
Version Model Number501440
Catalog Number501440
Company DUNS305524696
Company NameColoplast A/S
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)258-3476
Emailurology@coloplast.com

Device Dimensions

Length24 Centimeter
Width8 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932483964 [Primary]

FDA Product Code

OTOMesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-22

On-Brand Devices [Restorelle]

05708932528108Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y Contour™
05708932484084Direct Fix™ Posterior Polypropylene Mesh
05708932484022Direct Fix™ Anterior Polypropylene Mesh
05708932483964Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - L
05708932483896Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y
05708932483834Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - Y
05708932483285Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - XL
05708932483223Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - M

Trademark Results [Restorelle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTORELLE
RESTORELLE
86897886 not registered Dead/Abandoned
Plexus Worldwide, LLC
2016-02-04
RESTORELLE
RESTORELLE
77519425 not registered Dead/Abandoned
PHARMAVITE LLC
2008-07-10
RESTORELLE
RESTORELLE
77455364 3764024 Live/Registered
COLOPLAST A/S
2008-04-23

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