Straight Connection Rod

GUDID 06912547394907

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06912547394907
• NIH Device Record Key: 661b6854-f417-4b08-a258-75453f25801a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Connection Rod
• Version Model Number: 803795500
• 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	06912547394907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170861

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

Moist Heat or Steam Sterilization

[06912547394907]

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: 2017-12-12

On-Brand Devices [Straight Connection Rod]

• 06912547394907: 803795500
• 06912547394891: 803795250
• 06912547394884: 803795150
• 06912547394877: 803795140
• 06912547394860: 803795130
• 06912547394853: 803795120
• 06912547394846: 803795110
• 06912547394839: 803795105
• 06912547394822: 803795100
• 06912547394815: 803795095
• 06912547394808: 803795090
• 06912547394792: 803795085
• 06912547394785: 803795080
• 06912547394778: 803795075
• 06912547394761: 803795070
• 06912547394754: 803795065
• 06912547394747: 803795060
• 06912547394730: 803795055
• 06912547394723: 803795050
• 06912547394716: 803795045
• 06912547394709: 803795040
• 06912547394693: 803795035
• 06912547394686: 803795030
• 06912547394679: 803795025