Connection Rod

GUDID 06912547138044

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06912547138044
• NIH Device Record Key: 5f6c23e9-0383-4cdd-b4b4-8fb4dbe3e3a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Connection Rod
• Version Model Number: 8005030
• 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	06912547138044 [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

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

Moist Heat or Steam Sterilization

[06912547138044]

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 [Connection Rod]

• 06912547138266: 8005500
• 06912547138259: 8005250
• 06912547138242: 8005150
• 06912547138235: 8005140
• 06912547138228: 8005130
• 06912547138211: 8005120
• 06912547138204: 8005110
• 06912547138198: 8005105
• 06912547138181: 8005100
• 06912547138174: 8005095
• 06912547138167: 8005090
• 06912547138150: 8005085
• 06912547138143: 8005080
• 06912547138136: 8005075
• 06912547138129: 8005070
• 06912547138112: 8005065
• 06912547138105: 8005060
• 06912547138099: 8005055
• 06912547138082: 8005050
• 06912547138075: 8005045
• 06912547138068: 8005040
• 06912547138051: 8005035
• 06912547138044: 8005030
• 06912547138037: 8005025