Pneumo-Matic

GUDID 20888937003677

14 Gauge Insufflation Needle

Coopersurgical, Inc.

Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle Simple pneumoperitoneum needle

• Primary Device ID: 20888937003677
• NIH Device Record Key: b50f27b2-5b84-4228-85e4-7c3ce3ade41b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneumo-Matic
• Version Model Number: 900-210
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter
• Length: 150 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003673 [Primary]
GS1	20888937003677 [Package]; Contains: 00888937003673; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970788

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: 2018-07-06
• Device Publish Date: 2016-06-07

On-Brand Devices [Pneumo-Matic]

• 20888937003677: 14 Gauge Insufflation Needle
• 20888937003660: 14 Gauge Insufflation Needle