Hook

GUDID 06939488339033

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06939488339033
• NIH Device Record Key: 11477aa8-8de5-42f9-b9cd-98e57e489695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hook
• Version Model Number: 8460012
• Company DUNS: 545249039
• Company Name: Shandong Weigao Orthopaedic Device Co., Ltd.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06939488339033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160320

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[06939488339033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [Hook]

• 06939488339040: 8460013
• 06939488339033: 8460012
• 06939488339026: 8460011
• 06939488339019: 8460010
• 06939488339002: 8460009
• 06939488338999: 8460008
• 06939488338982: 8460007