93 NeuFlex Catheter 100148-002

GUDID 00860010306345

The 93 NeuFlex Catheter (100148-002) has an inner diameter of 0.093" (6F compatible), a maximum outer diameter of 0.110", and a working length of 100 cm.

PIRAEUS MEDICAL INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00860010306345
• NIH Device Record Key: e76675e2-60bd-4cf4-9186-f5090be9061b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 93 NeuFlex Catheter
• Version Model Number: 100148-002
• Catalog Number: 100148-002
• Company DUNS: 128420207
• Company Name: PIRAEUS MEDICAL 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 Identifiers

Device Issuing Agency	Device ID
GS1	00860010306345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251044

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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: 2025-06-26
• Device Publish Date: 2025-06-18

On-Brand Devices [93 NeuFlex Catheter]

• 00860010306345: The 93 NeuFlex Catheter (100148-002) has an inner diameter of 0.093" (6F compatible), a maximum
• 00860010306338: The 93 NeuFlex Catheter (100148-001) has an inner diameter of 0.093” (6F compatible), a maximu