1006241

GUDID 00814723020401

Sling Mesh

ENDO PHARMACEUTICALS INC.

Stress urinary incontinence surgical mesh, female
Primary Device ID00814723020401
NIH Device Record Key0edc1842-fac3-4258-b4f7-9b19f8e48fe8
Commercial Distribution Discontinuation2016-03-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number1006241
Catalog Number1006241
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
GS100814723020401 [Primary]

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

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00814723020319 - Monarc2019-04-23 Monarc
00814723020340 - Monarc2019-04-23 Monarc +

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