SCANLAN® Instruments 9009-364

GUDID 00846159014914

Endoscopic Jacobson Needle Holder, round handle, 30-degree angle, Diamond Dust™ jaws, 12.25" / 31 cm

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159014914
• NIH Device Record Key: d319affc-b01b-4355-b3e2-dc02cef57edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Instruments
• Version Model Number: 9009-364
• Catalog Number: 9009-364
• 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: 651-298-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159014914 [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

[00846159014914]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-13
• Device Publish Date: 2019-12-05

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• 00846159014914: Endoscopic Jacobson Needle Holder, round handle, 30-degree angle, Diamond Dust™ jaws, 12.25" /