Amniocentesis Needle

GUDID 07350025915531

Vitrolife Sweden AB

Amniocentesis kit, non-medicated

• Primary Device ID: 07350025915531
• NIH Device Record Key: 71b1f1ce-b9c2-4029-9a09-3a9fa759255d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amniocentesis Needle
• Version Model Number: 17801
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07350025915531 [Primary]
GS1	17350025915538 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• HIO: Sampler, Amniotic Fluid (Amniocentesis Tray)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-09

On-Brand Devices [Amniocentesis Needle]

• 07350025915531: 17801
• 17350025912285: 14801