Amniocentesis Needle

GUDID 17350025912285

Vitrolife Sweden AB

Amniocentesis kit, non-medicated

• Primary Device ID: 17350025912285
• NIH Device Record Key: 70462c25-995c-4959-811a-c7fc47722f25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amniocentesis Needle
• Version Model Number: 14801
• Company DUNS: 631805488
• Company Name: Vitrolife Sweden AB
• 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	07350025912288 [Primary]
GS1	17350025912285 [Package]; Contains: 07350025912288; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862365

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [Amniocentesis Needle]

• 07350025915531: 17801
• 17350025912285: 14801