SCANLAN® 9009-650-12-1

GUDID 00846159030280

Jacobson Needle Holder without Ratchet, curved left

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159030280
• NIH Device Record Key: 54ef54db-9b4d-4bdb-880b-773aeb7597fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN®
• Version Model Number: 9009-650-12-1
• Catalog Number: 9009-650-12-1
• 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	00846159030280 [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

[00846159030280]

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: 2016-02-01

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