Amielle Cone Size 4 SM 2174

GUDID 00384702174017

Amielle is intended to be inserted into the vagina and progressively dilate the vagina

OWEN MUMFORD LIMITED

Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator Vaginal dilator
Primary Device ID00384702174017
NIH Device Record Key2cb4566c-011d-4e39-8921-734b0aeffd78
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmielle Cone Size 4
Version Model NumberSM 2174
Catalog NumberSM 2174
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk
Phone+441993812021
Emailinfo@owenmumford.co.uk

Device Dimensions

Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384702104007 [Unit of Use]
GS100384702174007 [Unit of Use]
GS100384702174017 [Primary]
GS100384702174031 [Package]
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXPStent, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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