SIENTRA Nasal Implant 72-060U

GUDID 00812790023202

Nasal Implant, 'L', Solid Silicone White, 10/40 Sh A, Smooth, 58 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	00812790023202
NIH Device Record Key	791ce25c-2008-46e7-a71a-3739a303bbb2
Commercial Distribution Status	In Commercial Distribution
Brand Name	SIENTRA Nasal Implant
Version Model Number	72-060U
Catalog Number	72-060U
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	58 Millimeter
Length	58 Millimeter
Length	58 Millimeter
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Length	58 Millimeter
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Length	58 Millimeter
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Length	58 Millimeter
Length	58 Millimeter
Length	58 Millimeter
Length	58 Millimeter
Length	58 Millimeter
Length	58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790023202 [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