AdvantageRib 323.0071

GUDID 00854865007335

Small Cannulated AO Quick-Connect Handle

SIG MEDICAL CORP.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00854865007335
• NIH Device Record Key: e4c48726-1aae-40c7-99cf-c9ea29506828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvantageRib
• Version Model Number: 323.0071
• Catalog Number: 323.0071
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854865007335 [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

[00854865007335]

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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