NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LX-410515

GUDID 10888628003378

STYLE 410, LX, 515G BIOCELL |textured|contour|silicone

Allergan, Inc.

Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface

• Primary Device ID: 10888628003378
• NIH Device Record Key: fe03fda4-3b89-4340-9629-57221d195860
• Commercial Distribution Discontinuation: 2019-07-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
• Version Model Number: LX-410515
• Catalog Number: LX-410515
• Company DUNS: 144796497
• Company Name: Allergan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com
• Phone: 8006244261
• Email: ProductSupport@allergan.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628003378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040046

FDA Product Code

• FTR: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-10
• Device Publish Date: 2015-08-05

On-Brand Devices [NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants]

• 10888628003392: STYLE 410, LX, 625G BIOCELL |textured|contour|silicone
• 10888628003385: STYLE 410, LX, 570G BIOCELL |textured|contour|silicone
• 10888628003378: STYLE 410, LX, 515G BIOCELL |textured|contour|silicone
• 10888628002807: STYLE 410, FM, 180G
• 10888628002791: STYLE 410, FM, 155G
• 10888628002616: STYLE 410, FF, 160G