SCANLAN® Minimally Invasive Instrument 9909-219

GUDID 00846159025736

Thoracoscopic DeBakey Clamp, curved tapered jaws

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159025736
• NIH Device Record Key: e637d59c-a57a-4a78-8afa-3bb4df7e79f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Minimally Invasive Instrument
• Version Model Number: 9909-219
• Catalog Number: 9909-219
• Company DUNS: 023055619
• Company Name: SCANLAN INTERNATIONAL 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-297-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159025736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945474

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846159025736]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-03
• Device Publish Date: 2019-11-25

On-Brand Devices [SCANLAN® Minimally Invasive Instrument]

• 00846159025736: Thoracoscopic DeBakey Clamp, curved tapered jaws
• 00846159012842: Thoracoscopic DeBakey Clamp, 10 mm, Harken #2, Ring Handle, 1 x 2 wide DeBakey jaws, with ratche
• 00846159012231: Thoracoscopic DeBakey Clamp, 10 mm, Harken #1, ring handle, 1x2 wide DeBakey jaws, with ratchet,
• 00846159035889: Suction Instrument