Sil-Select Stock with gentamicin

Basic Information

• Brand Name: Sil-Select Stock with gentamicin
• Primary DI: 54119670012860
• Version / Model: SIS100G (100ml with gentamicin)
• Company Name: Fertipro NV
• Labeler DUNS: 373904101
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-05-06
• Public Version Status: Update
• Public Device Record Key: d03811db-8063-46a9-873b-7c9880bc2d4e
• Distribution End Date: 2016-09-19

Device Description

Sil-Select Stock with gentamicin - SIS100_32G (100 ml) Sil-Select Stock™ is a solution of silane-coated sicila particles in a chemically defined, balanced salts solution with HEPES (pH buffer). Sil-Select Stock 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): Yes
• 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	54119670012860	GS1
Package	05411967000654	GS1		1	Not in Commercial Distribution	2016-09-19

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

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