twoplus Applicator

Primary DI: 08881300389024
Brand: twoplus Applicator
Company: HANNAH LIFE TECHNOLOGIES PTE. LTD.
Model: HC01
Device description: An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination.
Published: 2024-02-06
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
OTC: true
Single use: true

Product Codes#

Code, Name table
Code	Name
QYZ	At Home Intravaginal Insemination System

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QYZ	At Home Intravaginal Insemination System	Obstetrics/Gynecology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K232579	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K232579	000	Twoplus Applicator	Hannah Life Technologies Pte , Ltd.	2023-12-21	QYZ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
08881300389024	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
08881300389024	08881300389024	8881300389024

GMDN Terms#

Term, Definition table
Term	Definition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 659561833
Device count: 1
Lot or batch: true
Manufacturing date on label: true
Expiration date on label: true