JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW 6080-150-12

GUDID 06934955933219

Percutaneous Transluminal Angioplasty Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955933219
• NIH Device Record Key: 1740fa66-99fd-434b-80b1-97c957656854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
• Version Model Number: 6080-150-12
• Catalog Number: 6080-150-12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955933219 [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: 2024-08-19
• Device Publish Date: 2024-08-10

On-Brand Devices [JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW]

• 06934955934377: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934360: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934353: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934346: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934339: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934322: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934315: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934308: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934292: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934285: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934278: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934261: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934254: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934247: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934230: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934223: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934216: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934209: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934193: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934186: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934179: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934162: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934155: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934148: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934131: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934124: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934100: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934094: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934087: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934070: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934063: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934056: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934049: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934032: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934025: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934018: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955934001: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933998: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933981: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933974: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933967: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933950: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933943: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933936: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933929: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933912: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933905: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933899: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933882: Percutaneous Transluminal Angioplasty Balloon Catheter
• 06934955933875: Percutaneous Transluminal Angioplasty Balloon Catheter