FDA.reportPublic FDA data

Amielle

Primary DI
00384702174017
Brand
Amielle
Company
OWEN MUMFORD LIMITED
Model
SM 2174
Catalog number
SM 2174
Device description
Amielle Cone Size 4 is intended to be inserted into the vagina and progressively dilate the vagina
Published
2016-09-22
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
00384702174031PackageGS1100In Commercial Distribution
00384702174017PrimaryGS10
00384702104007Unit of UseGS10
00384702174007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384702174031003847021740313847021740310384702174031
00384702174017003847021740173847021740170384702174017
00384702104007003847021040073847021040070384702104007
00384702174007003847021740073847021740070384702174007

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
Length160Millimeter

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
+441993812021info@owenmumford.co.uk

Regulatory Flags#

DUNS number
217266915
Device count
100
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384703800014Autopen AN3800AN38002016-09-19
00384703810013Autopen AN3810AN38102016-09-19
00384700752019Unistik 2 Safety Lancets - Super 18GAT 07522020-04-16
00384701402012Unistik TouchAT 14022023-03-30
00384701402036Unistik TouchAT 14022023-03-30
00384700702014UnistikAT 07022020-04-16
00384700704018UnistikAT 07042020-04-16
00384700712013Unistik AT 07122020-04-16
00384700714017Unistik AT 07142020-04-16
00384700747015Unistik AT 07472020-04-16
00384701422010Unistik TouchAT 14222021-03-26
00384701442018Unistik Touch AT 14422021-03-26
00384701015014Unistik AT 10152023-02-07
00384701027017Unistik 3AT 10272023-02-07
00384701614019Unistik ProAT 16142023-02-07
00384701634017Unistik ProAT 16342023-02-07
00384701644016Unistik ProAT 16442023-02-07
00384701015038Unistik AT 10152023-02-07
00384701027024Unistik 3AT 10272023-02-07
00384701614033Unistik ProAT 16142023-02-07

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