MiniArc 9000261

GUDID 00814723020364

MiniArc Pro

ENDO PHARMACEUTICALS INC.

Stress urinary incontinence surgical mesh, female
Primary Device ID00814723020364
NIH Device Record Key24e6a873-e6c3-45b7-a3bc-e62989151601
Commercial Distribution Discontinuation2016-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMiniArc
Version Model Number9000261
Catalog Number9000261
Company DUNS178074951
Company NameENDO PHARMACEUTICALS INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com
Phone18448790787
Emailcrabtree.tim@endo.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store product in a clean, dry, dark area at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100814723020364 [Primary]

FDA Product Code

PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-23
Device Publish Date2015-10-24

On-Brand Devices [MiniArc]

00814723020364MiniArc Pro
00814723020104MiniArc Precise
00814723020036MiniArc

Trademark Results [MiniArc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MINIARC
MINIARC
77110106 3463304 Dead/Cancelled
AMS Research Corporation
2007-02-17
MINIARC
MINIARC
73721293 1538661 Dead/Cancelled
GTE PRODUCTS CORPORATION
1988-04-08
MINIARC
MINIARC
73294591 1187535 Dead/Cancelled
GTE Products Corporation
1981-01-26
MINIARC
MINIARC
72145042 0749033 Dead/Expired
CHEMETRON CORPORATION
1962-05-21

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