SIENTRA Nostril Retainer 1171-021U

GUDID 00812790023387

Nostril Retainer w/Fixation, Solid Silicone, Smooth, 21 mm

Sientra, Inc.

Intranasal splint, non-biodegradable
Primary Device ID00812790023387
NIH Device Record Key7ff86529-808a-4361-a265-1c3a8ec063e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Nostril Retainer
Version Model Number1171-021U
Catalog Number1171-021U
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Dimensions

Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter
Width21 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812790023387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-10
Device Publish Date2015-10-23

On-Brand Devices [SIENTRA Nostril Retainer]

00812790023462Nostril Retainer w/Fixation, Solid Silicone, Smooth, 29 mm
00812790023455Nostril Retainer w/Fixation, Solid Silicone, Smooth, 28 mm
00812790023448Nostril Retainer w/Fixation, Solid Silicone, Smooth, 27 mm
00812790023431Nostril Retainer w/Fixation, Solid Silicone, Smooth, 26 mm
00812790023424Nostril Retainer w/Fixation, Solid Silicone, Smooth, 25 mm
00812790023417Nostril Retainer w/Fixation, Solid Silicone, Smooth, 24 mm
00812790023400Nostril Retainer w/Fixation, Solid Silicone, Smooth, 23 mm
00812790023394Nostril Retainer w/Fixation, Solid Silicone, Smooth, 22 mm
00812790023387Nostril Retainer w/Fixation, Solid Silicone, Smooth, 21 mm
00812790023370Nostril Retainer w/Fixation, Solid Silicone, Smooth, 20 mm
00812790023356Nostril Retainer w/Fixation, Solid Silicone, Smooth, 18 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.