SIENTRA Vaginal Stent 3521-095U

GUDID 00812790024919

Vaginal Stent, Inflatable, 95 mm

Sientra, Inc.

Vaginal stent, expandable Vaginal stent, expandable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable Polymeric vaginal stent, non-bioabsorbable

• Primary Device ID: 00812790024919
• NIH Device Record Key: a3c25182-210f-47fc-aa37-b9605a6a219a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIENTRA Vaginal Stent
• Version Model Number: 3521-095U
• Catalog Number: 3521-095U
• 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: 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

• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790024919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974479

FDA Product Code

• KXP: Stent, Vaginal

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 Vaginal Stent]

• 00812790024940: Vaginal Stent, Inflatable, 160 mm
• 00812790024933: Vaginal Stent, Inflatable, 140 mm
• 00812790024926: Vaginal Stent, Inflatable, 120 mm
• 00812790024919: Vaginal Stent, Inflatable, 95 mm