Sapphire NC Plus

GUDID 06934955934643

Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06934955934643
• NIH Device Record Key: 8f347818-e4c8-4cf3-b213-7df7c422ee51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire NC Plus
• Version Model Number: 250-153-2U
• 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: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955934643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192344

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: 2019-11-05
• Device Publish Date: 2019-10-28

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• 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