SafeSharp Transseptal Needle CLICK198

GUDID 30858769006471

98cm Sharp Needle Curve 1 in Five Unit Box

PPMDM

Cardiac transseptal needle, single-use

• Primary Device ID: 30858769006471
• NIH Device Record Key: 03a9a916-326a-4d72-9ba5-45fee8d015fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSharp Transseptal Needle
• Version Model Number: CLICK198
• Catalog Number: CLICK198
• 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	00858769006470 [Primary]
GS1	30858769006471 [Package]; Contains: 00858769006470; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241042

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: 2024-07-10
• Device Publish Date: 2024-07-02

On-Brand Devices [SafeSharp Transseptal Needle]

• 30858769006471: 98cm Sharp Needle Curve 1 in Five Unit Box
• 30858769006457: 71cm Sharp Needle Curve 1 in Five Unit Box
• 30858769006440: 98cm Sharp Needle Curve 0 in Five Unit Box
• 30858769006426: 71cm Sharp Needle Curve 0 in Five Unit Box