AccessGUDID - DEVICE: Amielle (00384702178015)

GUDID

Device Identifier (DI) Information

Brand Name: Amielle
Version or Model: SM 2178
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SM 2178
Company Name: OWEN MUMFORD LIMITED

Primary DI Number: 00384702178015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 217266915 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11267	Vaginal dilator	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXP	Stent, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983045	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 116 Millimeter

Device Record Status

Public Device Record Key: e93539f4-2d76-443c-a9da-d5bed7464b16
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016