AccessGUDID - DEVICE: Sperm Select System (60888937003613)

GUDID

Device Identifier (DI) Information

Brand Name: Sperm Select System
Version or Model: SM600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 60888937003613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Contents: One syringe of Sperm Select non-pyrogenic sterile membrane filtered, one vial of Medium non-pyrogenic sterile membrane filtered, one syringe carrier, two 3ml syringe, two 20-G needle, one 21-g needle, one vial holder, one syringe plug and one name tag

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?
59858	Spermatozoa/semen motility medium supplement	A sterile supplemental solution intended to be added to the medium during semen preparation for use in assisted reproduction technique (ART) procedures so as to enhance semen fluidity and sperm motility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDR	Cap, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900308	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
Special Storage Condition, Specify: Store at 2-8 degrees C/36-47 degrees F. Protect from freezing.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 391e261b-f2c0-4e85-9456-1aa986508a21
Public Version Date: February 28, 2024
Public Version Number: 5
DI Record Publish Date: August 09, 2016