SPERMCARE Lower Layer - Gradient System 2222-100

GUDID 00859268006213

SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

INVITROCARE, INCORPORATED

IVF medium

• Primary Device ID: 00859268006213
• NIH Device Record Key: 6db8ac5d-750f-4754-8329-dce80448674c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPERMCARE Lower Layer - Gradient System
• Version Model Number: 2222-100
• Catalog Number: 2222-100
• Company DUNS: 190094230
• Company Name: INVITROCARE, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859268006213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053494

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SPERMCARE Lower Layer - Gradient System]

• 00859268006220: SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in E
• 00859268006213: SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in E
• 00859268006206: SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in E