Needle Free Transseptal Cannula TSC198

GUDID 30858769006181

98cm Transseptal Cannula Curve 1

PPMDM

Cardiac transseptal needle

• Primary Device ID: 30858769006181
• NIH Device Record Key: a75544a6-ef1e-4872-9640-50a5657a10a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Free Transseptal Cannula
• Version Model Number: TSC198
• Catalog Number: TSC198
• Company DUNS: 081047841
• Company Name: PPMDM
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858769006180 [Primary]
GS1	30858769006181 [Package]; Contains: 00858769006180; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172934

FDA Product Code

• DRC: Trocar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [Needle Free Transseptal Cannula]

• 30858769006181: 98cm Transseptal Cannula Curve 1
• 30858769006174: 89cm Transseptal Cannula Curve 1
• 30858769006167: 71cm Transseptal Cannula Curve 1
• 30858769006150: 98cm Transseptal Cannula Curve 0
• 30858769006143: 89cm Transseptal Cannula Curve 0
• 30858769006136: 71cm Transseptal Cannula Curve 0