Natrelle Inspira Cohesive Breast Implants SCL-460

GUDID 10888628029552

Natrelle Inspira SCL 460cc BI (US)

Allergan, Inc.

Silicone gel-filled breast implant

• Primary Device ID: 10888628029552
• NIH Device Record Key: d692820c-28ab-479d-94ed-2ffbe9cc2da0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natrelle Inspira Cohesive Breast Implants
• Version Model Number: SCL-460
• Catalog Number: SCL-460
• 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	10888628029552 [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: 2016-10-04

On-Brand Devices [Natrelle Inspira Cohesive Breast Implants]

• 10888628031425: Natrelle Inspira TCX 800cc BI (US)
• 10888628031418: Natrelle Inspira TCX 750cc BI (US)
• 10888628031401: Natrelle Inspira TCX 700cc BI (US)
• 10888628031395: Natrelle Inspira TCX 650cc BI (US)
• 10888628031388: Natrelle Inspira TCX 615cc BI (US)
• 10888628031371: Natrelle Inspira TCX 580cc BI (US)
• 10888628031364: Natrelle Inspira TCX 560cc BI (US)
• 10888628031357: Natrelle Inspira TCX 545cc BI (US)
• 10888628031340: Natrelle Inspira TCX 525cc BI (US)
• 10888628031333: Natrelle Inspira TCX 495cc BI (US)
• 10888628031326: Natrelle Inspira TCX 470cc BI (US)
• 10888628031319: Natrelle Inspira TCX 445cc BI (US)
• 10888628031302: Natrelle Inspira TCX 420cc BI (US)
• 10888628031296: Natrelle Inspira TCX 400cc BI (US)
• 10888628031289: Natrelle Inspira TCX 375cc BI (US)
• 10888628031272: Natrelle Inspira TCX 340cc BI (US)
• 10888628031265: Natrelle Inspira TCX 310cc BI (US)
• 10888628031258: Natrelle Inspira TCX 285cc BI (US)
• 10888628031241: Natrelle Inspira TCX 255cc BI (US)
• 10888628031234: Natrelle Inspira TCX 225cc BI (US)
• 10888628031227: Natrelle Inspira TCX 205cc BI (US)
• 10888628031210: Natrelle Inspira TCF 770cc BI (US)
• 10888628031203: Natrelle Inspira TCF 745cc BI (US)
• 10888628031197: Natrelle Inspira TCF 695cc BI (US)
• 10888628031180: Natrelle Inspira TCF 650cc BI (US)
• 10888628031173: Natrelle Inspira TCF 605cc BI (US)
• 10888628031166: Natrelle Inspira TCF 560cc BI (US)
• 10888628031159: Natrelle Inspira TCF 520cc BI (US)
• 10888628031142: Natrelle Inspira TCF 485cc BI (US)
• 10888628031135: Natrelle Inspira TCF 450cc BI (US)
• 10888628031128: Natrelle Inspira TCF 415cc BI (US)
• 10888628031111: Natrelle Inspira TCF 385cc BI (US)
• 10888628031104: Natrelle Inspira TCF 365cc BI (US)
• 10888628031098: Natrelle Inspira TCF 345cc BI (US)
• 10888628031081: Natrelle Inspira TCF 335cc BI (US)
• 10888628031074: Natrelle Inspira TCF 325cc BI (US)
• 10888628031067: Natrelle Inspira TCF 295cc BI (US)
• 10888628031050: Natrelle Inspira TCF 265cc BI (US)
• 10888628031043: Natrelle Inspira TCF 240cc BI (US)
• 10888628031036: Natrelle Inspira TCF 220cc BI (US)
• 10888628031029: Natrelle Inspira TCF 200cc BI (US)
• 10888628031012: Natrelle Inspira TCF 180cc BI (US)
• 10888628031005: Natrelle Inspira TCM 755cc BI (US)
• 10888628030992: Natrelle Inspira TCM 685cc BI (US)
• 10888628030985: Natrelle Inspira TCM 640cc BI (US)
• 10888628030978: Natrelle Inspira TCM 600cc BI (US)
• 10888628030961: Natrelle Inspira TCM 560cc BI (US)
• 10888628030954: Natrelle Inspira TCM 520cc BI (US)
• 10888628030947: Natrelle Inspira TCM 485cc BI (US)
• 10888628030930: Natrelle Inspira TCM 445cc BI (US)