Embolectomy Catheter EC-0001-003

GUDID 08886483507524

BIOPTIMAL INTERNATIONAL PTE. LTD.

Thrombectomy balloon catheter

• Primary Device ID: 08886483507524
• NIH Device Record Key: 7e60f415-f7db-4f52-ae84-c063ab34b1be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embolectomy Catheter
• Version Model Number: EL3340
• Catalog Number: EC-0001-003
• Company DUNS: 595182247
• Company Name: BIOPTIMAL INTERNATIONAL PTE. 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886483507524 [Primary]

FDA Product Code

• DXE: Catheter, Embolectomy

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: 2023-11-08
• Device Publish Date: 2023-10-31

Devices Manufactured by BIOPTIMAL INTERNATIONAL PTE. LTD.

• 08886483501492 - Thermodilution Catheter and Accessories: 2023-11-13
• 08886483501393 - Thermodilution Catheter and Accessories: 2023-11-08
• 08886483501560 - Thermodilution Catheter and Accessories: 2023-11-08
• 08886483501829 - BIOTRANS™ Pressure Monitoring Kits: 2023-11-08
• 08886483502949 - BIOTRANS™ Pressure Monitoring Kits: 2023-11-08
• 08886483505636 - Central Venous Catheter Kit: 2023-11-08
• 08886483506008 - Central Venous Catheter Kit: 2023-11-08
• 08886483507524 - Embolectomy Catheter: 2023-11-08
• 08886483507524 - Embolectomy Catheter: 2023-11-08