FDA.reportPublic FDA data

SIENTRA Vaginal Stent

Primary DI
00812790024940
Brand
SIENTRA Vaginal Stent
Company
Sientra, Inc.
Model
3521-160U
Catalog number
3521-160U
Device description
Vaginal Stent, Inflatable, 160 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
KXPStent, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXPStent, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974479000SILIMED VAGINAL STENTSilimed, LLC1998-08-05KXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812790024940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812790024940008127900249408127900249400812790024940

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal stent, expandableA sterile non-bioabsorbable expandable device designed for long-term placement in the vagina to provide support and/or to prevent shrinking. It is especially used in the treatment of vaginal agenesis involving surgical intervention (e.g., to hold a skin graft postoperatively) or without surgical intervention, for the prevention of vaginal contracture or stenosis after radiotherapy, or for vaginal dilation following transgender vaginoplasty. It is available in many different configurations, sizes, and materials (e.g., an inflatable tubular silicone-elastomer envelope with valves and internal drains) and may be inserted and expanded with a balloon catheter or dilator.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length160Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551002932ALLURA®PMT CORPORATIONKXP2025-03-19
00650551003229ALLURA®PMT CORPORATIONKXP2025-03-19
00650551003236ALLURA®PMT CORPORATIONKXP2025-03-19
00650551003458ALLURA®PMT CORPORATIONKXP2025-03-19
00650551005148ALLURA®PMT CORPORATIONKXP2025-03-19
00650551147619ALLURA®PMT CORPORATIONKXP2025-03-19
00650551002758ALLURAPMT CORPORATIONKXP2021-10-27
00650551002222ALLURAPMT CORPORATIONKXP2021-09-20
00650551002239ALLURAPMT CORPORATIONKXP2021-09-20
00650551002246ALLURAPMT CORPORATIONKXP2021-09-20
00650551002253ALLURAPMT CORPORATIONKXP2021-09-20
00650551002260ALLURAPMT CORPORATIONKXP2021-09-20
00650551002277ALLURAPMT CORPORATIONKXP2021-09-20
00650551002284ALLURAPMT CORPORATIONKXP2021-09-20
00650551002666ALLURAPMT CORPORATIONKXP2021-09-20
00384702171016Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702172013Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702173010Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702174017AmielleOWEN MUMFORD LIMITEDKXP2016-09-22
00384702178015Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702179012Amielle OWEN MUMFORD LIMITEDKXP2016-09-22
00384702190017AmielleOWEN MUMFORD LIMITEDKXP2016-09-22
00384702100016AmielleOWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702100030AmielleOWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702101013Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702102010Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702103017Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702104014Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00384702105011Amielle OWEN MUMFORD USA INCORPORATEDKXP2016-09-19
00812790024919SIENTRA Vaginal StentSientra, Inc.KXP2015-10-23