Wahoo SF7072-105

GUDID 00857545008004

SelectFlex 072 Neurovascular Access System, 105cm

Q Apel Medical LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00857545008004
• NIH Device Record Key: 108a19ca-132c-4734-a881-fa871c2d82b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wahoo
• Version Model Number: FG 00074
• Catalog Number: SF7072-105
• 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	00857545008004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191664

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

Devices Manufactured by Q Apel Medical LLC

• 00857545008004 - Wahoo: 2021-07-07SelectFlex 072 Neurovascular Access System, 105cm
• 00857545008004 - Wahoo: 2021-07-07 SelectFlex 072 Neurovascular Access System, 105cm
• 00857545008011 - Walrus: 2021-07-07 087 Balloon Guide Catheter System, 90cm
• 00857545008028 - Walrus: 2021-07-07 087 Balloon Guide Catheter System, 95cm