FDA.reportPublic FDA data

SIENTRA Nostril Retainer

Primary DI
00812790023387
Brand
SIENTRA Nostril Retainer
Company
Sientra, Inc.
Model
1171-021U
Catalog number
1171-021U
Device description
Nostril Retainer w/Fixation, Solid Silicone, Smooth, 21 mm
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980221000SILIMED NASAL RETAINERSilimed, LLC1998-04-02LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812790023387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812790023387008127900233878127900233870812790023387

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width21Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-708-0808customer.experience@sientra.com

Regulatory Flags#

DUNS number
010209877
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076894621Sientra Viality-1400Viality-1400Viality-14002023-03-13
00812790023196SIENTRA Nasal Implant71-060U71-060U2015-10-23
00812790023202SIENTRA Nasal Implant72-060U72-060U2015-10-23
00812790028191AlloX2 Tissue ExpanderAlloX2-FH11SEAlloX2-FH11SE2020-05-19
00812790028207AlloX2 Tissue ExpanderAlloX2-FH12SEAlloX2-FH12SE2020-05-19
00812790028214AlloX2 Tissue ExpanderAlloX2-FH13SEAlloX2-FH13SE2020-05-19
00812790028221AlloX2 Tissue ExpanderAlloX2-FH14SEAlloX2-FH14SE2020-05-19
00812790028238AlloX2 Tissue ExpanderAlloX2-FH15SEAlloX2-FH15SE2020-05-19
00812790028245AlloX2 Tissue ExpanderAlloX2-FH16SEAlloX2-FH16SE2020-05-19
00812790028252AlloX2 Tissue ExpanderAlloX2-FH11EAlloX2-FH11E2020-05-19
00812790028269AlloX2 Tissue ExpanderAlloX2-FH12EAlloX2-FH12E2020-05-19
00812790028276AlloX2 Tissue ExpanderAlloX2-FH13EAlloX2-FH13E2020-05-19
00812790028283AlloX2 Tissue ExpanderAlloX2-FH14EAlloX2-FH14E2020-05-19
00812790028290AlloX2 Tissue ExpanderAlloX2-FH15EAlloX2-FH15E2020-05-19
00812790028306AlloX2 Tissue ExpanderAlloX2-FH16EAlloX2-FH16E2020-05-19
00812790028313AlloX2 Tissue ExpanderAlloX2-12SEAlloX2-12SE2020-05-19
00812790028320AlloX2 Tissue ExpanderAlloX2-13SEAlloX2-13SE2020-05-19
00812790028337AlloX2 Tissue ExpanderAlloX2-14SEAlloX2-14SE2020-05-19
00812790028344AlloX2 Tissue ExpanderAlloX2-15SEAlloX2-15SE2020-05-19
00812790028351AlloX2 Tissue ExpanderAlloX2-16SEAlloX2-16SE2020-05-19

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