AlloX2 Tissue Expander AlloX2-FH15SE

GUDID 00812790028238

Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 600-720 cc

Sientra, Inc.

Skin-port tissue expander

• Primary Device ID: 00812790028238
• NIH Device Record Key: a20828f5-9073-4bb4-b1be-5419251ec1d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlloX2 Tissue Expander
• Version Model Number: AlloX2-FH15SE
• Catalog Number: AlloX2-FH15SE
• 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: true
• 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

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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790028238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140383

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: 2
• Public Version Date: 2023-10-25
• Device Publish Date: 2020-05-19

On-Brand Devices [AlloX2 Tissue Expander]

• 00812790028405: Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 580-690 cc
• 00812790028399: Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 500-600 cc
• 00812790028382: Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 460-550 cc
• 00812790028375: Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 340-420 cc
• 00812790028368: Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 225-280 cc
• 00812790028351: Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 580-690 cc
• 00812790028344: Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 500-600 cc
• 00812790028337: Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 460-550 cc
• 00812790028320: Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 340-420 cc
• 00812790028313: Tissue Expander, Smooth Surface, Integrated Ports, Mid Height, 225-280 cc
• 00812790028306: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 750-900 cc
• 00812790028290: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 600-750 cc
• 00812790028283: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 480-575 cc
• 00812790028276: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 360-430 cc
• 00812790028269: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 270-330 cc
• 00812790028252: Tissue Expander, Textured Surface, Integrated Ports, Full Height, 230-280 cc
• 00812790028245: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 750-900 cc
• 00812790028238: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 600-720 cc
• 00812790028221: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 480-575 cc
• 00812790028214: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 360-430 cc
• 00812790028207: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 270-330 cc
• 00812790028191: Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 230-280 cc