SFG Sperm Collection Container

Basic Information

• Brand Name: SFG Sperm Collection Container
• Primary DI: 10850068289537
• Version / Model: S-D-SC
• Company Name: SPECTRUM FERTILITY GROUP INC.
• Labeler DUNS: 119292307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2024-11-12
• Public Version: 1
• Public Version Date: 2024-11-20
• Public Version Status: New
• Public Device Record Key: 99aacde3-ac2f-4cc8-9b9d-d61fed8df301

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63772	Semen specimen collection container	A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850068289530	GS1
Primary	10850068289537	GS1