SPARC 1006228

GUDID 00814723020425

SPARC Needle Passers

ENDO PHARMACEUTICALS INC.

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 00814723020425
• NIH Device Record Key: 122571ad-e2e7-4254-8ca8-60e77a2af4b2
• Commercial Distribution Discontinuation: 2016-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SPARC
• Version Model Number: 1006228
• Catalog Number: 1006228
• Company DUNS: 178074951
• Company Name: ENDO PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com
• Phone: 18448790787
• Email: crabtree.tim@endo.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a clean, dry, dark area at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814723020425 [Primary]

FDA Product Code

• OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-10-24

On-Brand Devices [SPARC]

• 00814723020425: SPARC Needle Passers
• 00814723020296: SPARC