Sil-Select Plus

Basic Information

• Brand Name: Sil-Select Plus
• Primary DI: 54119670001802
• Version / Model: SIP016
• Company Name: Fertipro NV
• Labeler DUNS: 373904101
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 26d1da58-1c67-4b98-94f5-4061d692ec72
• Distribution End Date: 2017-09-30

Device Description

Sil-Select Plus™ (SIP016) This kit contains the following product codes: 2 x 20 ml Sil-Select Plus Upper Layer 2 x 20 ml Sil-Select Plus Lower Layer 2 x 20 ml washing/insemination medium Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Plus has a 18 month shelf life from date of manufacturer For the latest version of the intructions for use and MSDS, visit our product page on the FertiPro's website (www.fertipro.com)

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44046	IVF medium	A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	54119670001802	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius