V-ONESTEP V-OSM-10

GUDID 04260650070013

V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).

VITROMED GmbH

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• Primary Device ID: 04260650070013
• NIH Device Record Key: e429ee05-722c-4b02-8512-0ccbec63ad7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-ONESTEP
• Version Model Number: V-OSM-10
• Catalog Number: V-OSM-10
• Company DUNS: 315234102
• Company Name: VITROMED GmbH
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260650070013 [Primary]
GS1	04260650071713 [Package]; Package: Board box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193285

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-12
• Device Publish Date: 2022-04-04

On-Brand Devices [V-ONESTEP]

• 04260650070013: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages
• 04260650072437: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages
• 04260650071614: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages
• 04260650070020: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages