JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW 5960-240-12

GUDID 06934955937583

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955937583
• NIH Device Record Key: 70ee097e-f89e-45af-a4c2-486c9f3f5140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
• Version Model Number: 5960-240-12
• Catalog Number: 5960-240-12
• 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

Customer Support Contacts

• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com
• Phone: 13128973283
• Email: gxia@orbusneich.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955937583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241025

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2024-08-05
• Device Publish Date: 2024-07-27

On-Brand Devices [JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW]

• 06934955937415: Percutaneous Transluminal Angioplasty Balloon Cathet
• 06934955937408: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937392: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937385: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937378: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937361: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937354: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937347: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937330: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937323: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937316: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937309: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937293: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937286: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937279: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937262: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937255: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937248: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937231: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937224: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937217: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937200: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937194: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937187: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937170: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937163: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937156: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937149: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937132: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937125: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937118: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937101: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937095: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937088: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937071: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937064: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937057: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937040: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937026: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937019: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955937002: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936999: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936982: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936975: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936968: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936951: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936944: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936937: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936920: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955936913: Percutaneous Transluminal Angioplasty Balloon Catheter