SCANLAN® Minimally Invasive Instruments 9009-221

GUDID 00846159032185

Thoracoscopic Grasper

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159032185
• NIH Device Record Key: babc1432-cdd4-4439-8b5e-cba94000f9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Minimally Invasive Instruments
• Version Model Number: 9009-221
• Catalog Number: 9009-221
• 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	00846159032185 [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

[00846159032185]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-21
• Device Publish Date: 2016-09-08

On-Brand Devices [SCANLAN® Minimally Invasive Instruments]

• 00846159032192: Thoracoscopic Grasper
• 00846159032185: Thoracoscopic Grasper