Align® TO Trans-Obturator Urethral Support System - Hook BRD400HK

GUDID 00801741016219

ALIGN® TO Urethral Support System, Hook

C. R. Bard, Inc.

Stress urinary incontinence surgical mesh, female 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 ID: 00801741016219
• NIH Device Record Key: 5b899e1d-36b2-40eb-877b-a0e463f0c8b4
• Commercial Distribution Discontinuation: 2016-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Align® TO Trans-Obturator Urethral Support System - Hook
• Version Model Number: BRD400HK
• Catalog Number: BRD400HK
• Company DUNS: 016898496
• Company Name: C. R. Bard, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741016219 [Primary]
GS1	10801741016216 [Package]; Package: Other [1 Units]; Discontinued: 2016-12-31; Not in Commercial Distribution

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: 2015-09-14

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