AdvantageRib 323.1005

GUDID 00854865007045

AdvantageRib Locking Cap, Small, Hex Drive

SIG MEDICAL CORP.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00854865007045
• NIH Device Record Key: 4a40fbbf-cb11-4804-97eb-d5108efeb56f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvantageRib
• Version Model Number: 323.1005
• Catalog Number: 323.1005
• Company DUNS: 080503619
• Company Name: SIG MEDICAL CORP.
• 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: false
• Manufacturing Date: true
• 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: 7175532021
• Email: customerservice@sigmedical.net
• Phone: 7175532021
• Email: customerservice@sigmedical.net

Device Dimensions

• Length: 4.55 Millimeter
• Length: 4.55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854865007045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141241

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00854865007045]

Moist Heat or Steam Sterilization

[00854865007045]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-04
• Device Publish Date: 2017-02-17

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• 00854865007519: AdvantageRib Short Bridge and 23mm Locking Posts
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• 00854865007489: AdvantageRib Short Bridge and 10mm Locking Posts