AccessGUDID - DEVICE: LensHooke Sperm Separation Device (24719874742267)

GUDID

Device Identifier (DI) Information

Brand Name: LensHooke Sperm Separation Device
Version or Model: CA0 Package-150 sets-EN-CE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA0
Company Name: BONRAYBIO CO., LTD.

Primary DI Number: 24719874742267
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 150
Labeler D-U-N-S® Number*: 658872369 *Terms of Use

Device Description: No description.

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?
17987	Sperm filtration system	An assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221810	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 38 Degrees Celsius
Handling Environment Temperature: between 59 and 100 Degrees Fahrenheit
Handling Environment Humidity: less than 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a10cb57b-0d97-4cf9-a15f-bf66dbeb73d1
Public Version Date: April 21, 2025
Public Version Number: 2
DI Record Publish Date: April 10, 2025