Jade PTA

GUDID 06934955940828

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955940828
• NIH Device Record Key: f80f386a-9576-4e4c-9dfb-df3b43e71182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jade PTA
• Version Model Number: L540-50080U
• 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

• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 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	06934955940828 [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