SafeSept Transseptal Guidwire SS-135

GUDID 30858769006105

0.014" Transseptal guidewire.

PPMDM

Cardiac transseptal needle

• Primary Device ID: 30858769006105
• NIH Device Record Key: 04aaf13f-d6c8-4581-aa52-2c2645b1cf90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSept Transseptal Guidwire
• Version Model Number: SS-135
• Catalog Number: SS-135
• 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	00858769006104 [Primary]
GS1	30858769006105 [Package]; Contains: 00858769006104; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170671

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

Devices Manufactured by PPMDM

• 30858769006426 - SafeSharp Transseptal Needle: 2024-07-10 71cm Sharp Needle Curve 0 in Five Unit Box
• 30858769006440 - SafeSharp Transseptal Needle: 2024-07-10 98cm Sharp Needle Curve 0 in Five Unit Box
• 30858769006457 - SafeSharp Transseptal Needle: 2024-07-10 71cm Sharp Needle Curve 1 in Five Unit Box
• 30858769006471 - SafeSharp Transseptal Needle: 2024-07-10 98cm Sharp Needle Curve 1 in Five Unit Box
• 30858769006419 - SafeSept Transseptal Guidewire: 2022-10-04 0.018" Transseptal Guidewire
• 00858769006357 - SafeSept Blunt Needle: 2021-03-23 71cm Transseptal Extended Cannula Curve 0
• 30858769006365 - SafeSept Blunt Needle: 2021-03-23 89cm Transseptal Extended Cannula Curve 0
• 30858769006372 - SafeSept Blunt Needle: 2021-03-23 98cm Transseptal Extended Cannula Curve 0