Sapphire ULTRA Coronary Dilatation Catheter

GUDID 06934955979453

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06934955979453
• NIH Device Record Key: 8aff93a5-3f92-492d-9e09-7809d99b2436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire ULTRA Coronary Dilatation Catheter
• Version Model Number: 7940-020-11
• 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	06934955979453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233505

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [Sapphire ULTRA Coronary Dilatation Catheter]

• 06934955979453: 7940-020-11
• 06934955979446: 7940-015-11
• 06934955979439: 7940-010-11
• 06934955979422: 7935-030-11
• 06934955979415: 7935-020-11
• 06934955979408: 7935-015-11
• 06934955979392: 7935-010-11
• 06934955979385: 7932-020-11
• 06934955979378: 7932-015-11
• 06934955979361: 7932-010-11
• 06934955979354: 7930-030-11
• 06934955979347: 7930-020-11
• 06934955979330: 7930-015-11
• 06934955979323: 7930-012-11
• 06934955979316: 7930-010-11
• 06934955979309: 7927-020-11
• 06934955979293: 7927-015-11
• 06934955979286: 7927-010-11
• 06934955979279: 7925-030-11
• 06934955979262: 7925-020-11
• 06934955979255: 7925-015-11
• 06934955979248: 7925-012-11
• 06934955979231: 7925-010-11
• 06934955979224: 7922-020-11
• 06934955979217: 7922-015-11
• 06934955979200: 7922-010-11
• 06934955979194: 7920-020-11
• 06934955979187: 7920-015-11
• 06934955979170: 7920-012-11
• 06934955979163: 7920-010-11
• 06934955979156: 7917-020-11
• 06934955979149: 7917-015-11
• 06934955979132: 7917-010-11
• 06934955979125: 7915-020-11
• 06934955979118: 7915-015-11
• 06934955979101: 7915-012-11
• 06934955979095: 7915-010-11
• 06934955979088: 7912-015-11
• 06934955979071: 7912-010-11
• 06934955979064: 7912-008-11
• 06934955979057: 7912-005-11
• 06934955979040: 7910-015-11
• 06934955979033: 7910-010-11
• 06934955979026: 7910-008-11
• 06934955979019: 7910-005-11