SCANLAN® Thoracoscopic DeBakey Clamp 9909-213

GUDID 00846159026184

CardioVasive™ Thoracoscopic DeBakey Clamp (10mm), Straight 1 x 2 DeBakey Jaw, 14" / 35.6 cm

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159026184
• NIH Device Record Key: dfd5ef48-3a43-4607-98be-574502184cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Thoracoscopic DeBakey Clamp
• Version Model Number: 9909-213
• Catalog Number: 9909-213
• 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	00846159026184 [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

[00846159026184]

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® Thoracoscopic DeBakey Clamp]

• 00846159029161: Chitwood, Debakey Clamp, 10mm, 2X3 jaw,angled shanks,curved left, 8 cm jaw / 20.5cm
• 00846159026191: CardioVasive™ Thoracoscopic DeBakey Clamp (10 mm), 45 degree angled left jaw, (10.5 cm jaw len
• 00846159026184: CardioVasive™ Thoracoscopic DeBakey Clamp (10mm), Straight 1 x 2 DeBakey Jaw, 14" / 35.6 cm
• 00846159026177: CardioVasive™ Thoracoscopic DeBakey Clamp (10 mm), Straight Jaw, (5 cm jaw length; 23 cm worki