Enhance Water for Tissue Culture

GUDID 00008053608495

Enhance Water for Tissue Culture, 1.5 Liter

VITROLIFE INC.

Sterile solution storage bottle, single-use

• Primary Device ID: 00008053608495
• NIH Device Record Key: fa9612a7-ffbd-475c-9ebe-2c4ebf099001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enhance Water for Tissue Culture
• Version Model Number: 15522
• Company DUNS: 051915038
• Company Name: VITROLIFE INC.
• 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	00008053608495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993140

FDA Product Code

• MTW: System, Water, Reproduction, Assisted, And Purification

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: 2019-10-23
• Device Publish Date: 2018-04-23

On-Brand Devices [Enhance Water for Tissue Culture]

• 00008053608495: Enhance Water for Tissue Culture, 1.5 Liter
• 00805360018494: Enhance Water for Tissue Culture, 1.5 Liter