Dermaspan Tissue Expander LPP-FH13-RS

GUDID 00812790029075

Tissue Expander, Smooth Surface, Remote Port, Full Height, 360-430 cc

Sientra, Inc.

Skin-port tissue expander

• Primary Device ID: 00812790029075
• NIH Device Record Key: 45893f18-de83-49ac-b289-bc186b1c96c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermaspan Tissue Expander
• Version Model Number: LPP-FH13-RS
• Catalog Number: LPP-FH13-RS
• Company DUNS: 010209877
• Company Name: Sientra, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00812790029075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070303

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: 2020-05-21

On-Brand Devices [Dermaspan Tissue Expander]

• 00812790029105: Tissue Expander, Smooth Surface, Remote Port, Full Height, 750-900 cc
• 00812790029099: Tissue Expander, Smooth Surface, Remote Port, Full Height, 600-720 cc
• 00812790029082: Tissue Expander, Smooth Surface, Remote Port, Full Height, 480-575 cc
• 00812790029075: Tissue Expander, Smooth Surface, Remote Port, Full Height, 360-430 cc
• 00812790029068: Tissue Expander, Smooth Surface, Remote Port, Full Height, 310-370 cc
• 00812790029051: Tissue Expander, Smooth Surface, Remote Port, Full Height, 250-300 cc
• 00812790029044: Tissue Expander, Textured Surface, Remote Port, Full Height, 750-900 cc
• 00812790029037: Tissue Expander, Textured Surface, Remote Port, Full Height, 600-720 cc
• 00812790029020: Tissue Expander, Textured Surface, Remote Port, Full Height, 480-575 cc
• 00812790029013: Tissue Expander, Textured Surface, Remote Port, Full Height, 360-430 cc
• 00812790029006: Tissue Expander, Textured Surface, Remote Port, Full Height, 310-370 cc
• 00812790028993: Tissue Expander, Textured Surface, Remote Port, Full Height, 250-300 cc
• 00812790028986: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 580-690 cc
• 00812790028979: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 500-600 cc
• 00812790028962: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 460-550 cc
• 00812790028955: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 380-450 cc
• 00812790028948: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 310-370 cc
• 00812790028931: Tissue Expander, Smooth Surface, Remote Port, Mid Height, 250-300 cc
• 00812790028924: Tissue Expander, Textured Surface, Remote Port, Mid Height, 580-690 cc
• 00812790028917: Tissue Expander, Textured Surface, Remote Port, Mid Height, 500-600 cc
• 00812790028900: Tissue Expander, Textured Surface, Remote Port, Mid Height, 460-550 cc
• 00812790028894: Tissue Expander, Textured Surface, Remote Port, Mid Height, 380-450 cc
• 00812790028887: Tissue Expander, Textured Surface, Remote Port, Mid Height, 310-370 cc
• 00812790028870: Tissue Expander, Textured Surface, Remote Port, Mid Height, 250-300 cc
• 00812790028863: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 750-900 cc
• 00812790028856: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 600-720 cc
• 00812790028849: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 480-575 cc
• 00812790028832: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 360-430 cc
• 00812790028825: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 310-370 cc
• 00812790028818: Tissue Expander, Smooth Surface, Integrated Port, Full Height, 250-300 cc
• 00812790028801: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 580-690 cc
• 00812790028795: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 500-600 cc
• 00812790028788: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 460-550 cc
• 00812790028771: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 380-450 cc
• 00812790028764: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 310-370 cc
• 00812790028757: Tissue Expander, Smooth Surface, Integrated Port, Mid Height, 250-300 cc
• 00812790028740: Tissue Expander, Textured Surface, Integrated Port, Full Height, 750-900 cc
• 00812790028733: Tissue Expander, Textured Surface, Integrated Port, Full Height, 600-720 cc
• 00812790028726: Tissue Expander, Textured Surface, Integrated Port, Full Height, 480-575 cc
• 00812790028719: Tissue Expander, Textured Surface, Integrated Port, Full Height, 360-430 cc
• 00812790028702: Tissue Expander, Textured Surface, Integrated Port, Full Height, 310-370 cc
• 00812790028696: Tissue Expander, Textured Surface, Integrated Port, Full Height, 250-300 cc
• 00812790028689: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 580-690 cc
• 00812790028672: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 500-600 cc
• 00812790028665: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 460-550 cc
• 00812790028658: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 380-450 cc
• 00812790028641: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 310-370 cc
• 00812790028634: Tissue Expander, Textured Surface, Integrated Port, Mid Height, 250-300 cc