ArcTV™ Transvaginal Sling System A-TV-1001

GUDID 00860368002401

ArcTV™ Transvaginal Sling System

UROCURE LLC

Stress urinary incontinence surgical mesh, female Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Primary Device ID00860368002401
NIH Device Record Key2b39e4de-02c1-41c9-a345-a494ae9571d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameArcTV™ Transvaginal Sling System
Version Model NumberA-TV-1001
Catalog NumberA-TV-1001
Company DUNS117159885
Company NameUROCURE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com
Phone6124660117
Emailinfo@urocure.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860368002401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-21
Device Publish Date2019-08-13

Trademark Results [ArcTV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARCTV
ARCTV
87848250 5932865 Live/Registered
UroCure, L.L.C.
2018-03-24

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