Sil-Select Plus Lower Layer

GUDID 54119670011566

Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced sal

Fertipro NV

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium

• Primary Device ID: 54119670011566
• NIH Device Record Key: f3fd776d-7693-41e7-9185-a77d187a8011
• Commercial Distribution Discontinuation: 2018-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sil-Select Plus Lower Layer
• Version Model Number: SIP100LO
• Company DUNS: 373904101
• Company Name: Fertipro NV
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com
• Phone: +3250791805
• Email: info@fertipro.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	54119670011566 [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: 2018-05-03
• Device Publish Date: 2016-09-19

On-Brand Devices [Sil-Select Plus Lower Layer]

• 54119670011634: Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved
• 54119670011566: Sil-Select Plus Lower Layer - SIP100LO (100 ml) Sil-Select Plus™ is a solution of silane-coate
• 54119670010880: Sil-Select Plus Lower Layer - SIP050LO (50 ml) Sil-Select Plus™ is a solution of silane-coated
• 54119670010712: Sil-Select Plus Lower Layer - SIP042LO (4,2ml) Sil-Select Plus™ is a solution of silane-coated
• 54119670010576: Sil-Select Plus Lower Layer - SIP025LO (2,5ml) Sil-Select Plus™ is a solution of silane-coated
• 54119670010262: Sil-Select Plus™ Sperm preparation media Sil-Select Plus™ is our home made new and improved
• 54119670010194: Sil-Select Plus Lower Layer - SIP020LO (20 ml) Sil-Select Plus™ is a solution of silane-coate
• 54119670009822: Sil-Select Plus Lower Layer - SIP012LO (12 ml) Sil-Select Plus™ is a solution of silane-coate