AdvantageRib 323.1202

GUDID 00854865007380

AdvantageRib Locking Post, 18mm

SIG MEDICAL CORP.

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

• Primary Device ID: 00854865007380
• NIH Device Record Key: 3ccc0545-c95c-4fde-833b-3f44063d5887
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvantageRib
• Version Model Number: 323.1202
• Catalog Number: 323.1202
• 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: 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: 717-553-2021
• Email: info@sigmedical.net
• Phone: 717-553-2021
• Email: info@sigmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854865007380 [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

[00854865007380]

Moist Heat or Steam Sterilization

[00854865007380]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-10-03

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