Sapphire NC ULTRA Coronary Dilatation Catheter

GUDID 06934955982262

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06934955982262
• NIH Device Record Key: 488a6ca9-510b-4d87-881d-573ae98775a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire NC ULTRA Coronary Dilatation Catheter
• Version Model Number: 8230-008-11
• 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	06934955982262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233499

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

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: 2025-01-28
• Device Publish Date: 2025-01-20

On-Brand Devices [Sapphire NC ULTRA Coronary Dilatation Catheter]

• 06934955982606: 8250-018-11
• 06934955982590: 8250-015-11
• 06934955982583: 8250-012-11
• 06934955982576: 8250-010-11
• 06934955982569: 8250-008-11
• 06934955982552: 8245-018-11
• 06934955982545: 8245-015-11
• 06934955982538: 8245-012-11
• 06934955982521: 8245-010-11
• 06934955982514: 8245-008-11
• 06934955982507: 8240-018-11
• 06934955982491: 8240-015-11
• 06934955982484: 8240-012-11
• 06934955982477: 8240-010-11
• 06934955982460: 8240-008-11
• 06934955982453: 8237-018-11
• 06934955982446: 8237-015-11
• 06934955982439: 8237-012-11
• 06934955982422: 8237-010-11
• 06934955982415: 8237-008-11
• 06934955982408: 8235-018-11
• 06934955982392: 8235-015-11
• 06934955982385: 8235-012-11
• 06934955982378: 8235-010-11
• 06934955982361: 8235-008-11
• 06934955982354: 8232-018-11
• 06934955982347: 8232-015-11
• 06934955982330: 8232-012-11
• 06934955982323: 8232-010-11
• 06934955982316: 8232-008-11
• 06934955982309: 8230-018-11
• 06934955982293: 8230-015-11
• 06934955982286: 8230-012-11
• 06934955982279: 8230-010-11
• 06934955982262: 8230-008-11
• 06934955982255: 8227-018-11
• 06934955982248: 8227-015-11
• 06934955982231: 8227-012-11
• 06934955982224: 8227-010-11
• 06934955982217: 8227-008-11
• 06934955982200: 8225-018-11
• 06934955982194: 8225-015-11
• 06934955982187: 8225-012-11
• 06934955982170: 8225-010-11
• 06934955982163: 8225-008-11
• 06934955982156: 8222-018-11
• 06934955982149: 8222-015-11
• 06934955982132: 8222-012-11
• 06934955982125: 8222-010-11
• 06934955982118: 8222-008-11