AccessGUDID - DEVICE: NA (08057509880031)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: CO7026
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INGE SPA

Primary DI Number: 08057509880031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 21
Labeler D-U-N-S® Number*: 338946150 *Terms of Use

Device Description: Kit including 21 cannulas for administering semi-solid preparation into 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:	Yes
Prescription Use (Rx):	No
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?
32652	Vaginal applicator, reusable	A device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGD	Applicator, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d91db36b-98b6-425a-9123-4a064100aeaa
Public Version Date: August 25, 2022
Public Version Number: 2
DI Record Publish Date: July 17, 2022