NATRELLE INSPIRA Single Use Sizers SSZ-X615

GUDID 10888628045934

Natrelle Inspira X-Full 615cc SSZ US

Allergan, Inc.

Invasive breast implant sizer, fixed, single-use

• Primary Device ID: 10888628045934
• NIH Device Record Key: 7f9252db-a848-484f-aa3d-17a8e790e398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATRELLE INSPIRA Single Use Sizers
• Version Model Number: SSZ-X615
• Catalog Number: SSZ-X615
• 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	10888628045934 [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

On-Brand Devices [NATRELLE INSPIRA Single Use Sizers ]

• 10888628045972: Natrelle Inspira X-Full 800cc SSZ US
• 10888628045965: Natrelle Inspira X-Full 750cc SSZ US
• 10888628045958: Natrelle Inspira X-Full 700cc SSZ US
• 10888628045941: Natrelle Inspira X-Full 650cc SSZ US
• 10888628045934: Natrelle Inspira X-Full 615cc SSZ US
• 10888628045927: Natrelle Inspira X-Full 580cc SSZ US
• 10888628045910: Natrelle Inspira X-Full 560cc SSZ US
• 10888628045903: Natrelle Inspira X-Full 545cc SSZ US
• 10888628045897: Natrelle Inspira X-Full 525cc SSZ US
• 10888628045880: Natrelle Inspira X-Full 495cc SSZ US
• 10888628045873: Natrelle Inspira X-Full 470cc SSZ US
• 10888628045866: Natrelle Inspira X-Full 445cc SSZ US
• 10888628045859: Natrelle Inspira X-Full 420cc SSZ US
• 10888628045842: Natrelle Inspira X-Full 400cc SSZ US
• 10888628045835: Natrelle Inspira X-Full 375cc SSZ US
• 10888628045828: Natrelle Inspira X-Full 340cc SSZ US
• 10888628045811: Natrelle Inspira X-Full 310cc SSZ US
• 10888628045804: Natrelle Inspira X-Full 285cc SSZ US
• 10888628045798: Natrelle Inspira X-Full 255cc SSZ US
• 10888628045781: Natrelle Inspira X-Full 225cc SSZ US
• 10888628045774: Natrelle Inspira X-Full 205cc SSZ US
• 10888628045187: Natrelle Inspira FullProf 770cc SSZ US
• 10888628045170: Natrelle Inspira FullProf 745cc SSZ US
• 10888628045163: Natrelle Inspira FullProf 695cc SSZ US
• 10888628045156: Natrelle Inspira FullProf 650cc SSZ US
• 10888628045149: Natrelle Inspira FullProf 605cc SSZ US
• 10888628045132: Natrelle Inspira FullProf 560cc SSZ US
• 10888628045125: Natrelle Inspira FullProf 520cc SSZ US
• 10888628045118: Natrelle Inspira FullProf 485cc SSZ US
• 10888628045101: Natrelle Inspira FullProf 450cc SSZ US
• 10888628045095: Natrelle Inspira FullProf 415cc SSZ US
• 10888628045088: Natrelle Inspira FullProf 385cc SSZ US
• 10888628045071: Natrelle Inspira FullProf 365cc SSZ US
• 10888628045064: Natrelle Inspira FullProf 345cc SSZ US
• 10888628045057: Natrelle Inspira FullProf 335cc SSZ US
• 10888628045040: Natrelle Inspira FullProf 325cc SSZ US