6F Wallaby Long Sheath

GUDID 06970908211980

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter.

Shanghai Wallaby Medical Technologies Co., Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 06970908211980
• NIH Device Record Key: 1608dd6d-b8d7-40a9-ae21-148d893f68d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6F Wallaby Long Sheath
• Version Model Number: SH6F100ST
• 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	06970908211980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222603

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [6F Wallaby Long Sheath]

• 06970908211997: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari
• 06970908211980: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari
• 06970908211973: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari
• 06970908211966: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari
• 06970908211959: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari
• 06970908211942: The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, vari