Scoreflex NC Scoring PTCA Catheter

GUDID 06934955936258

OrbusNeich Medical (ShenZhen) Co., Ltd.

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• Primary Device ID: 06934955936258
• NIH Device Record Key: f58329bf-4586-4aa2-accf-ec74254a3e1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scoreflex NC Scoring PTCA Catheter
• Version Model Number: 617-104-1U
• Company DUNS: 530923226
• Company Name: OrbusNeich Medical (ShenZhen) Co., Ltd.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955936258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200041

FDA Product Code

• NWX: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

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: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Scoreflex NC Scoring PTCA Catheter]

• 06934955936487: 640-204-1U
• 06934955936470: 640-154-1U
• 06934955936463: 640-104-1U
• 06934955936456: 635-204-1U
• 06934955936449: 635-154-1U
• 06934955936432: 635-104-1U
• 06934955936425: 630-204-1U
• 06934955936418: 630-154-1U
• 06934955936401: 630-104-1U
• 06934955936395: 627-204-1U
• 06934955936388: 627-154-1U
• 06934955936371: 627-104-1U
• 06934955936364: 625-204-1U
• 06934955936357: 625-154-1U
• 06934955936340: 625-104-1U
• 06934955936333: 622-204-1U
• 06934955936326: 622-154-1U
• 06934955936319: 622-104-1U
• 06934955936302: 620-204-1U
• 06934955936296: 620-154-1U
• 06934955936289: 620-104-1U
• 06934955936272: 617-204-1U
• 06934955936265: 617-154-1U
• 06934955936258: 617-104-1U