Esperance

GUDID 06970908211126

Thrombectomy suction catheter

Shanghai Wallaby Medical Technologies Co., Inc.

Thrombectomy suction catheter

• Primary Device ID: 06970908211126
• NIH Device Record Key: ad49847b-8491-4c94-8658-913a78a0a651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esperance
• Version Model Number: ASP6F125KIT
• Company DUNS: 544535295
• Company Name: Shanghai Wallaby Medical Technologies Co., Inc.
• 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	06970908211126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211697

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2022-06-10
• Device Publish Date: 2022-06-02

On-Brand Devices [Esperance]

• 06970908211874: Thrombectomy suction catheter
• 06970908211867: Thrombectomy suction catheter
• 06970908211850: Thrombectomy suction catheter
• 06970908211133: Thrombectomy suction catheter
• 06970908211126: Thrombectomy suction catheter
• 06970908211119: Thrombectomy suction catheter
• 06970908211935: 5F Distal access catheter
• 06970908211928: 5F Distal access catheter
• 06970908211911: 5F Distal access catheter
• 06970908211195: 6F Distal access catheter
• 06970908211188: 6F Distal access catheter
• 06970908211171: 6F Distal access catheter