AccessGUDID - DEVICE: Visitec® (30886158006665)

GUDID

Device Identifier (DI) Information

Brand Name: Visitec®
Version or Model: 585229
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 585229
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158006665
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: Soft Tip Cannula .50 x 33mm (25G x 1.3 in) 3mm tip

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):	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?
47605	Vaginal douche, single-use	A non-sterile, manual device designed to produce and direct a stream of fluid (typically water, water/vinegar solution, or antiseptic chemicals) into the vaginal cavity typically for hygienic purposes, including the removal of vaginal discharge, medicinal deposits, and anticonceptual products from the vagina. It usually consists of a squeeze bottle to contain the fluid, typically prefilled, with an attached nozzle for vaginal insertion; the fluid is ejected upon hand compression by the user. The device is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic

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: Yes
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: 284c6691-0fe2-4f04-94aa-fb53a7aa9d87
Public Version Date: December 28, 2021
Public Version Number: 1
DI Record Publish Date: December 20, 2021