Jade PTA Balloon Dilatation Catheter

GUDID 06934955955273

Percutaneous Transluminal Angioplasty (PTA) 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

• Primary Device ID: 06934955955273
• NIH Device Record Key: ae5392b3-9948-4f16-9d3f-173758d46e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jade PTA Balloon Dilatation Catheter
• Version Model Number: 552524012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955955273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202231

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: 2021-01-04
• Device Publish Date: 2020-12-25

On-Brand Devices [Jade PTA Balloon Dilatation Catheter]

• 06934955960901: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955960826: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955960536: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955960505: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955960376: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955960345: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955904936: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955904783: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955904639: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903953: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903915: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903434: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903397: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903229: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903182: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902260: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902246: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902239: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902222: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902208: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902192: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902185: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902178: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902161: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902154: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902147: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902130: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902123: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902116: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902109: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902093: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902086: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903106: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903090: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903083: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903076: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903069: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903052: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903045: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903038: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903021: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903014: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955903007: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902994: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902970: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902963: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902956: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902949: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902932: Percutaneous Transluminal Angioplasty (PTA) Catheter
• 06934955902925: Percutaneous Transluminal Angioplasty (PTA) Catheter