NATRELLE Silicone-Filled Breast Implants 15-158

GUDID 10888628001381

NATRELLE Style 15-158 Gel Round Mod Plus

Allergan, Inc.

Silicone gel-filled breast implant

• Primary Device ID: 10888628001381
• NIH Device Record Key: 075a8aa5-dda1-4423-8ef4-24d37ddb5b79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATRELLE Silicone-Filled Breast Implants
• Version Model Number: 15-158
• Catalog Number: 15-158
• 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888628001381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020056

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-17

On-Brand Devices [NATRELLE Silicone-Filled Breast Implants]

• 10888628002609: NATRELLE Style 120-650 Gel BIOCELL High
• 10888628002593: NATRELLE Style 120-600 Gel BIOCELL High
• 10888628002586: NATRELLE Style 120-550 Gel BIOCELL High
• 10888628002579: NATRELLE Style 120-500 Gel BIOCELL High
• 10888628002562: NATRELLE Style 120-440 Gel BIOCELL High
• 10888628002555: NATRELLE Style 120-400 Gel BIOCELL High
• 10888628002548: NATRELLE Style 120-340 Gel BIOCELL High
• 10888628002531: NATRELLE Style 120-300 Gel BIOCELL High
• 10888628002524: NATRELLE Style 120-260 Gel BIOCELL High
• 10888628002517: NATRELLE Style 120-220 Gel BIOCELL High
• 10888628002500: NATRELLE Style 120-180 Gel BIOCELL High
• 10888628002494: NATRELLE St 115-716 Gel BIOCELL Mod Plus
• 10888628002487: NATRELLE St 115-666 Gel BIOCELL Mod Plus
• 10888628002470: NATRELLE St 115-627 Gel BIOCELL Mod Plus
• 10888628002463: NATRELLE St 115-586 Gel BIOCELL Mod Plus
• 10888628002456: NATRELLE St 115-547 Gel BIOCELL Mod Plus
• 10888628002449: NATRELLE St 115-507 Gel BIOCELL Mod Plus
• 10888628002432: NATRELLE St 115-469 Gel BIOCELL Mod Plus
• 10888628002425: NATRELLE St 115-435 Gel BIOCELL Mod Plus
• 10888628002418: NATRELLE St 115-401 Gel BIOCELL Mod Plus
• 10888628002401: NATRELLE St 115-378 Gel BIOCELL Mod Plus
• 10888628002395: NATRELLE St 115-354 Gel BIOCELL Mod Plus
• 10888628002388: NATRELLE St 115-322 Gel BIOCELL Mod Plus
• 10888628002371: NATRELLE St 115-290 Gel BIOCELL Mod Plus
• 10888628002364: NATRELLE St 115-272 Gel BIOCELL Mod Plus
• 10888628002357: NATRELLE St 115-253 Gel BIOCELL Mod Plus
• 10888628002340: NATRELLE St 115-222 Gel BIOCELL Mod Plus
• 10888628002333: NATRELLE St 115-203 Gel BIOCELL Mod Plus
• 10888628002326: NATRELLE St 115-185 Gel BIOCELL Mod Plus
• 10888628002319: NATRELLE St 115-167 Gel BIOCELL Mod Plus
• 10888628002302: NATRELLE St 115-150 Gel BIOCELL Mod Plus
• 10888628002296: NATRELLE Style 110-510 Gel BIOCELL Mod
• 10888628002289: NATRELLE Style 110-480 Gel BIOCELL Mod
• 10888628002272: NATRELLE Style 110-450 Gel BIOCELL Mod
• 10888628002265: NATRELLE Style 110-420 Gel BIOCELL Mod
• 10888628002258: NATRELLE Style 110-390 Gel BIOCELL Mod
• 10888628002241: NATRELLE Style 110-360 Gel BIOCELL Mod
• 10888628002234: NATRELLE Style 110-330 Gel BIOCELL Mod
• 10888628002227: NATRELLE Style 110-300 Gel BIOCELL Mod
• 10888628002210: NATRELLE Style 110-270 Gel BIOCELL Mod
• 10888628002203: NATRELLE Style 110-240 Gel BIOCELL Mod
• 10888628002197: NATRELLE Style 110-210 Gel BIOCELL Mod
• 10888628002180: NATRELLE Style 110-180 Gel BIOCELL Mod
• 10888628002173: NATRELLE Style 110-150 Gel BIOCELL Mod
• 10888628002166: NATRELLE Style 110-120 Gel BIOCELL Mod
• 10888628002159: NATRELLE Style 110-090 Gel BIOCELL Mod
• 10888628002142: NATRELLE Sty 45-800 Gel Round Extra High
• 10888628002135: NATRELLE Sty 45-700 Gel Round Extra High
• 10888628002128: NATRELLE Sty 45-650 Gel Round Extra High
• 10888628002111: NATRELLE Sty 45-600 Gel Round Extra High