Jade PTA

GUDID 06934955940675

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955940675
• NIH Device Record Key: 5e482705-3fef-45e3-b9ae-f6c5391335a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jade PTA
• Version Model Number: L540-35040U
• 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
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com
• Phone: 954-730-0711
• Email: jpazienza@orbusneich.com

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 40 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.
• 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	06934955940675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173894

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-04
• Device Publish Date: 2018-03-16

On-Brand Devices [Jade PTA]

• 06934955940927: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940910: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940903: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940897: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940880: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940873: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940866: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940859: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940842: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940835: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940828: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940811: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940804: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940798: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940781: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940774: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940767: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940750: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940743: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940736: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940729: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940712: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940705: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940699: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940682: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940675: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940668: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940651: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940644: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940637: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940620: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940613: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940606: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940590: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940583: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940576: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940569: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940552: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940545: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940538: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940521: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940514: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940507: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940491: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940484: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955940477: Percutaneous Transluminal Angioplasty Balloon Catheter