FDA.reportPublic FDA data

Amielle

Primary DI
00384702102010
Brand
Amielle
Company
OWEN MUMFORD USA INCORPORATED
Model
SM 2102
Catalog number
SM 2102
Device description
Amielle cone size 1
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K983045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983045000AMIELLEOwen Mumford USA, Inc.1998-11-25KXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384702102034PackageGS120In Commercial Distribution
00384702102010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384702102034003847021020343847021020340384702102034
00384702102010003847021020103847021020100384702102010

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length89Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-977-2226info@owenmumfordinc.com

Regulatory Flags#

DUNS number
803401454
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059507093Unifine PentipsAN 3550AC2024-05-17
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707102015Unistik VacuFlipBC 71022023-10-06

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
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
00812790024926SIENTRA Vaginal StentSientra, Inc.KXP2015-10-23