Jade PTA Balloon Dilatation Catheter

GUDID 06934955955969

Percutaneous Transluminal Angioplasty (PTA) Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955955969
• NIH Device Record Key: baf27bd5-7c26-4bbc-a46d-4947a6123cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jade PTA Balloon Dilatation Catheter
• Version Model Number: 557008012
• 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	06934955955969 [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