Sapphire NC Plus

GUDID 06934955916823

Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06934955916823
• NIH Device Record Key: 3024e9ab-67e0-483a-8c88-7f45ff2f2166
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire NC Plus
• Version Model Number: 235-103-2U
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955916823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162209

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-01-19

On-Brand Devices [Sapphire NC Plus]

• 06934955916953: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916946: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916939: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916922: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916915: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter 4.0x8mm
• 06934955916908: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916892: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916885: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916878: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916861: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916854: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916847: Percutaneous Transluminal Coronary Angioplasty (PTCA) BalloonCatheter
• 06934955916830: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916823: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916816: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916809: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916793: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916786: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916779: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916762: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916755: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916748: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916731: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916724: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916717: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916700: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916694: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916687: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916670: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916663: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916656: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916649: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916632: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916625: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916618: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916601: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916595: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916588: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916571: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916564: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916557: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916540: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916533: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916526: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955916519: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955934650: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955934643: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955934636: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955934629: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
• 06934955934612: Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter