NATRELLE INSPIRA Single Use Sizers SSZ-X445

GUDID 10888628045866

Natrelle Inspira X-Full 445cc SSZ US

Allergan, Inc.

Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use

• Primary Device ID: 10888628045866
• NIH Device Record Key: fbc7d01d-7000-47b1-a3b2-e34ed71733d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATRELLE INSPIRA Single Use Sizers
• Version Model Number: SSZ-X445
• Catalog Number: SSZ-X445
• 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	10888628045866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203229

FDA Product Code

• MRD: Sizer, Mammary, Breast Implant Volume

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: 2022-01-17
• Device Publish Date: 2022-01-07

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• 10888628045866: Natrelle Inspira X-Full 445cc SSZ US
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• 10888628045187: Natrelle Inspira FullProf 770cc SSZ US
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