SIENTRA Anatomical Controlled Tissue Expander (ACX) 20719-830ACX

GUDID 00812790022113

Anatomical Controlled Tissue Expander, Moderate Height, ACX, 830 cc

Sientra, Inc.

Skin-port tissue expander

• Primary Device ID: 00812790022113
• NIH Device Record Key: 7bd93657-2b1d-4792-935a-beb457f683aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIENTRA Anatomical Controlled Tissue Expander (ACX)
• Version Model Number: 20719-830ACX
• Catalog Number: 20719-830ACX
• Company DUNS: 010209877
• Company Name: Sientra, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790022113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981852

FDA Product Code

• LCJ: Expander, Skin, Inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-10-23

On-Brand Devices [SIENTRA Anatomical Controlled Tissue Expander (ACX)]

• 00812790022298: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 780 cc
• 00812790022281: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 620 cc
• 00812790022274: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 570 cc
• 00812790022267: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 470 cc
• 00812790022250: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 390 cc
• 00812790022243: Anatomical Controlled Tissue Expander, Double Chamber, ACX, 310 cc
• 00812790022236: Anatomical Controlled Tissue Expander, Low Height, ACX, 840 cc
• 00812790022229: Anatomical Controlled Tissue Expander, Low Height, ACX, 690 cc
• 00812790022212: Anatomical Controlled Tissue Expander, Low Height, ACX, 540 cc
• 00812790022205: Anatomical Controlled Tissue Expander, Low Height, ACX, 470 cc
• 00812790022199: Anatomical Controlled Tissue Expander, Low Height, ACX, 390 cc
• 00812790022182: Anatomical Controlled Tissue Expander, Low Height, ACX, 320 cc
• 00812790022175: Anatomical Controlled Tissue Expander, Full Height, ACX, 800 cc
• 00812790022168: Anatomical Controlled Tissue Expander, Full Height, ACX, 700 cc
• 00812790022151: Anatomical Controlled Tissue Expander, Full Height, ACX, 600 cc
• 00812790022144: Anatomical Controlled Tissue Expander, Full Height, ACX, 500 cc
• 00812790022137: Anatomical Controlled Tissue Expander, Full Height, ACX, 400 cc
• 00812790022120: Anatomical Controlled Tissue Expander, Full Height, ACX, 300 cc
• 00812790022113: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 830 cc
• 00812790022106: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 650 cc
• 00812790022090: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 535 cc
• 00812790022083: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 430 cc
• 00812790022076: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 340 cc
• 00812790022069: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 250 cc
• 00812790022052: Anatomical Controlled Tissue Expander, Moderate Height, ACX, 180 cc