Esperance

GUDID 06970908211935

5F Distal access catheter

Shanghai Wallaby Medical Technologies Co., Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 06970908211935
• NIH Device Record Key: 341b0038-dc67-4465-b44c-1ca94c7c938e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esperance
• Version Model Number: DAC5F115
• 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	06970908211935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231056

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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: 2024-03-29
• Device Publish Date: 2024-03-21

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• 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