PROTEUS 1U-3100-135-02

GUDID 07290014582163

ANGIOSLIDE LTD

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 07290014582163
• NIH Device Record Key: 44d34f94-6071-48eb-b00b-c5148d75dcf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEUS
• Version Model Number: 1U-3100-135-02
• Catalog Number: 1U-3100-135-02
• Company DUNS: 514451397
• Company Name: ANGIOSLIDE 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: false
• 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	07290014582163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133043

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: 2018-07-06
• Device Publish Date: 2017-08-30

On-Brand Devices [PROTEUS]

• 07290014582187: 1U-4100-135-02
• 07290014582170: 1U-0460-135-02
• 07290014582163: 1U-3100-135-02
• 07290014582149: 1U-0640-135-02
• 07290014582132: 1U-0620-135-02
• 07290014582118: 1U-0540-135-04
• 07290014582101: 1U-0520-135-02
• 07290014582095: 1U-0480-135-02
• 07290014582088: 1U-0440-135-02
• 07290014582071: 1U-0420-135-03
• 07290014582033: PROTEUS PTA Catheter with Embolic Capture Feature 6x60mm
• 07290014582026: PROTEUS PTA Catheter with Embolic Capture Feature 6x100mm
• 07290014582019: 1U-0560-135-03
• 07290014582002: 1U-5100-135-03