SIENTRA Gluteal Implant 20942-160U

GUDID 00812790023042

Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 275 cc

Sientra, Inc.

Silicone-block tissue reconstructive material

• Primary Device ID: 00812790023042
• NIH Device Record Key: 3f14f611-27c1-4bc0-8566-611749a5d6f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIENTRA Gluteal Implant
• Version Model Number: 20942-160U
• Catalog Number: 20942-160U
• 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

Device Dimensions

• 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
• 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
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• 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	00812790023042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974482

FDA Product Code

• MIB: Elastomer, Silicone Block

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 Gluteal Implant]

• 00812790023127: Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 440 cc
• 00812790023110: Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 340 cc
• 00812790023103: Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 290 cc
• 00812790023097: Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 250 cc
• 00812790023080: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 540 cc
• 00812790023073: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 435 cc
• 00812790023066: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 385 cc
• 00812790023059: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 343 cc
• 00812790023042: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 275 cc
• 00812790023035: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 233 cc
• 00812790023028: Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 145 cc
• 00812790023011: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 420 cc
• 00812790023004: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 385 cc
• 00812790022991: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 330 cc
• 00812790022984: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 300 cc
• 00812790022977: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 260 cc
• 00812790022960: Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 225 cc