Veress Needle

GUDID 24714127862006

UNIMAX MEDICAL SYSTEMS INC.

Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 24714127862006
• NIH Device Record Key: 977f1b5d-247e-4009-a1f0-3ff0e0ea53bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veress Needle
• Version Model Number: FVN112000
• Company DUNS: 658122465
• Company Name: UNIMAX MEDICAL SYSTEMS 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04714127862002 [Primary]
GS1	14714127862009 [Package]; Contains: 04714127862002; Package: Box [10 Units]; In Commercial Distribution
GS1	24714127862006 [Package]; Contains: 14714127862009; Package: Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111441

FDA Product Code

• FHO: Pneumoperitoneum Needle

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: 2019-11-18
• Device Publish Date: 2017-01-09

On-Brand Devices [Veress Needle]

• 24714127862020: FVN115000
• 24714127862006: FVN112000