SafeSept Blunt Needle SBN198

GUDID 30858769006402

98cm Transseptal Extended Cannula Curve 1

PPMDM

Cardiac transseptal needle, single-use

• Primary Device ID: 30858769006402
• NIH Device Record Key: b8146a89-9725-43e2-bff7-1e71b7316d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSept Blunt Needle
• Version Model Number: SBN198
• Catalog Number: SBN198
• 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	00858769006401 [Primary]
GS1	30858769006402 [Package]; Contains: 00858769006401; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210328

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: 1
• Public Version Date: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [SafeSept Blunt Needle]

• 30858769006402: 98cm Transseptal Extended Cannula Curve 1
• 30858769006396: 89cm Transseptal Extended Cannula Curve 1
• 30858769006389: 71cm Transseptal Extended Cannula Curve 1
• 30858769006372: 98cm Transseptal Extended Cannula Curve 0
• 30858769006365: 89cm Transseptal Extended Cannula Curve 0
• 00858769006357: 71cm Transseptal Extended Cannula Curve 0