AccessGUDID - DEVICE: twoplus Applicator (08881300389024)

GUDID

Device Identifier (DI) Information

Brand Name: twoplus Applicator
Version or Model: HC01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HANNAH LIFE TECHNOLOGIES PTE. LTD.

Primary DI Number: 08881300389024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659561833 *Terms of Use

Device Description: An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination.

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):	Yes
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?
64137	Home-use artificial insemination kit	A collection of devices intended to be used in the home for self or assisted intracervical insemination in order to promote conception. It includes containers for semen collection, tips for semen transfer into syringes, and syringes for the transfer of semen into the female reproductive tract. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QYZ	At Home Intravaginal Insemination System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232579	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b74d03d9-55df-4a88-aa1d-5a9ae619fbf8
Public Version Date: February 14, 2024
Public Version Number: 1
DI Record Publish Date: February 06, 2024