Peelaway Introducer Sheath, 14Fr 1305-014

GUDID 00810004820746

Peelaway Introducer Sheath, 14 French, Dome Tipped

CLARUS MEDICAL, LLC

Endoscope sheath, single-use

• Primary Device ID: 00810004820746
• NIH Device Record Key: 6088df92-1052-4dfc-b7c4-9484b54c7d08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peelaway Introducer Sheath, 14Fr
• Version Model Number: 1305-014
• Catalog Number: 1305-014
• Company DUNS: 010316284
• Company Name: CLARUS 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004820746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200925

FDA Product Code

• GWG: Endoscope, Neurological

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: 2021-05-05
• Device Publish Date: 2021-04-27

Devices Manufactured by CLARUS MEDICAL, LLC

• 00810004820173 - Forceps, Cup, Down, 2mm, 28.5cm: 2025-01-07 Forceps, Cup, Down, 2mm, 28.5cm
• 00810004820319 - Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down: 2025-01-07 Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down
• 00810004820326 - Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down: 2025-01-07 Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down
• 00810004820463 - Light Cable, ACMI-ACMI, 1mm: 2025-01-07 Light Cable, ACMI-ACMI, 1mm
• 00810004820760 - Forceps, Cup, Down, 2mm, 19.7cm: 2025-01-07 Forceps, Cup, Down, 2mm, 19.7cm
• 00810004820777 - Forceps, Grasping, Down, 2mm, 19.7cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 19.7cm
• 00810004820784 - Forceps, Grasping, Down, 2mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 2mm, 28.5cm
• 00810004820876 - Forceps, Grasping, Down, 3mm, 28.5cm: 2025-01-07 Forceps, Grasping, Down, 3mm, 28.5cm