Walrus BG8087-095

GUDID 00857545008028

087 Balloon Guide Catheter System, 95cm

Q Apel Medical LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00857545008028
• NIH Device Record Key: 21351a63-012e-4daf-9f0e-6a61577a20a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Walrus
• Version Model Number: FG 00100-02
• Catalog Number: BG8087-095
• Company DUNS: 129467906
• Company Name: Q Apel Medical LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857545008028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192525

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: 2021-07-07
• Device Publish Date: 2021-06-29

On-Brand Devices [Walrus]

• 00857545008028: 087 Balloon Guide Catheter System, 95cm
• 00857545008011: 087 Balloon Guide Catheter System, 90cm