Sil-Select Plus Lower Layer

GUDID 54119670010712

Sil-Select Plus Lower Layer - SIP042LO (4,2ml) Sil-Select Plus™ is a solution of silane-coated sicila particles in a chemically defined, balanced salt

Fertipro NV

IVF medium

• Primary Device ID: 54119670010712
• NIH Device Record Key: 300de95c-ae2b-414b-8524-c47175a1bb30
• Commercial Distribution Discontinuation: 2018-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sil-Select Plus Lower Layer
• Version Model Number: SIP042LO (4,2ml)
• 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	54119670010712 [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]

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• 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