SIENTRA Nasal Implant 71-060U

GUDID 00812790023196

Nasal Implant, 'L', Solid Silicone White, 25/50 Sh A, Smooth, 60 mm

Sientra, Inc.

Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable

• Primary Device ID: 00812790023196
• NIH Device Record Key: 50f6bdad-888e-4c27-b9af-3f7906179ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIENTRA Nasal Implant
• Version Model Number: 71-060U
• Catalog Number: 71-060U
• Company DUNS: 010209877
• Company Name: Sientra, 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: 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
• 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
• 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
• 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

• Length: 60 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790023196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981833

FDA Product Code

• FZE: Prosthesis, Nose, Internal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

On-Brand Devices [SIENTRA Nasal Implant]

• 00812790023202: Nasal Implant, 'L', Solid Silicone White, 10/40 Sh A, Smooth, 58 mm
• 00812790023196: Nasal Implant, 'L', Solid Silicone White, 25/50 Sh A, Smooth, 60 mm