Scoreflex PTA Scoring Balloon Catheter

GUDID 06934955941429

Catheter, Percutaneous, Cutting/Scoring

OrbusNeich Medical (ShenZhen) Co., Ltd.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06934955941429
• NIH Device Record Key: ec4f5267-af70-4ace-86c4-3a76da40a665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scoreflex PTA Scoring Balloon Catheter
• Version Model Number: BL645-404CU
• 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

• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter
• Balloon Diameter: 4.5 Millimeter
• Catheter Length: 150 Centimeter
• Guidewire Diameter: 0.018 Inch
• Balloon Length: 40 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934955941429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182713

FDA Product Code

• PNO: Catheter, Percutaneous, Cutting/Scoring

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: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [Scoreflex PTA Scoring Balloon Catheter]

• 06934955941511: Catheter, Percutaneous, Cutting/Scoring
• 06934955941504: Catheter, Percutaneous, Cutting/Scoring
• 06934955941498: Catheter, Percutaneous, Cutting/Scoring
• 06934955941481: Catheter, Percutaneous, Cutting/Scoring
• 06934955941474: Catheter, Percutaneous, Cutting/Scoring
• 06934955941467: Catheter, Percutaneous, Cutting/Scoring
• 06934955941450: Catheter, Percutaneous, Cutting/Scoring
• 06934955941443: Catheter, Percutaneous, Cutting/Scoring
• 06934955941436: Catheter, Percutaneous, Cutting/Scoring
• 06934955941429: Catheter, Percutaneous, Cutting/Scoring
• 06934955941412: Catheter, Percutaneous, Cutting/Scoring
• 06934955941405: Catheter, Percutaneous, Cutting/Scoring
• 06934955941399: Catheter, Percutaneous, Cutting/Scoring
• 06934955941382: Catheter, Percutaneous, Cutting/Scoring
• 06934955941375: Catheter, Percutaneous, Cutting/Scoring
• 06934955941368: Catheter, Percutaneous, Cutting/Scoring
• 06934955941351: Catheter, Percutaneous, Cutting/Scoring
• 06934955941344: Catheter, Percutaneous, Cutting/Scoring
• 06934955941337: Catheter, Percutaneous, Cutting/Scoring
• 06934955941320: Catheter, Percutaneous, Cutting/Scoring
• 06934955941313: Catheter, Percutaneous, Cutting/Scoring
• 06934955941306: Catheter, Percutaneous, Cutting/Scoring
• 06934955941290: Catheter, Percutaneous, Cutting/Scoring
• 06934955941283: Catheter, Percutaneous, Cutting/Scoring
• 06934955941276: Catheter, Percutaneous, Cutting/Scoring
• 06934955941252: Catheter, Percutaneous, Cutting/Scoring
• 06934955941245: Catheter, Percutaneous, Cutting/Scoring
• 06934955941238: Catheter, Percutaneous, Cutting/Scoring
• 06934955941221: Catheter, Percutaneous, Cutting/Scoring
• 06934955941214: Catheter, Percutaneous, Cutting/Scoring
• 06934955941207: Catheter, Percutaneous, Cutting/Scoring
• 06934955941191: Catheter, Percutaneous, Cutting/Scoring
• 06934955941184: Catheter, Percutaneous, Cutting/Scoring
• 06934955941177: Catheter, Percutaneous, Cutting/Scoring
• 06934955941160: Catheter, Percutaneous, Cutting/Scoring
• 06934955941153: Catheter, Percutaneous, Cutting/Scoring
• 06934955941146: Catheter, Percutaneous, Cutting/Scoring
• 06934955941139: Catheter, Percutaneous, Cutting/Scoring
• 06934955941122: Catheter, Percutaneous, Cutting/Scoring
• 06934955941115: Catheter, Percutaneous, Cutting/Scoring
• 06934955941108: Catheter, Percutaneous, Cutting/Scoring
• 06934955941092: Catheter, Percutaneous, Cutting/Scoring
• 06934955941085: Catheter, Percutaneous, Cutting/Scoring
• 06934955941078: Catheter, Percutaneous, Cutting/Scoring
• 06934955941061: Catheter, Percutaneous, Cutting/Scoring
• 06934955941054: Catheter, Percutaneous, Cutting/Scoring
• 06934955941047: Catheter, Percutaneous, Cutting/Scoring
• 06934955941030: Catheter, Percutaneous, Cutting/Scoring
• 06934955941023: Catheter, Percutaneous, Cutting/Scoring
• 06934955941016: Catheter, Percutaneous, Cutting/Scoring