AdvantageRib 04.517.010

GUDID 00854865007076

AdvantageRIB Fracture Kit, 60mm

SIG MEDICAL CORP.

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

• Primary Device ID: 00854865007076
• NIH Device Record Key: 4b591f1b-e45a-41c8-8f2a-e0e5d51a2feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvantageRib
• Version Model Number: 1
• Catalog Number: 04.517.010
• 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: 60 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854865007076 [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

[00854865007076]

Moist Heat or Steam Sterilization

[00854865007076]

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: 2017-02-17

On-Brand Devices [AdvantageRib]

• 00854865007441: AdvantageRib Folding Clamp, 4.0 Drill Sleeve
• 00854865007434: AdvantageRib Folding Clamp
• 00854865007427: AdvantageRib Washer, 9.5mm
• 00854865007403: AdvantageRib X-Driver, AO Quick-Connect
• 00854865007397: AdvantageRib Locking Post, 10mm
• 00854865007380: AdvantageRib Locking Post, 18mm
• 00854865007373: AdvantageRib Locking Post, 23mm
• 00854865007366: AdvantageRib Locking Cap, Large, X-Drive
• 00854865007359: AdvantageRib Locking Cap, Medium, X-Drive
• 00854865007342: AdvantageRib Locking Cap, X-Drive
• 00854865007335: Small Cannulated AO Quick-Connect Handle
• 00854865007328: AdvantageRib 4.0mm Drill, Brad Point
• 00854865007311: AdvantageRIB Fracture Kit, 75mm
• 00854865007304: AdvantageRIB Fracture Kit, 90mm
• 00854865007168: AdvantageRib Guide Cable
• 00854865007076: AdvantageRIB Fracture Kit, 60mm
• 00854865007069: AdvantageRib Locking Cap, Large, Hex Drive
• 00854865007052: AdvantageRib Locking Cap, Medium, Hex Drive
• 00854865007045: AdvantageRib Locking Cap, Small, Hex Drive
• 00854865007038: AdvantageRib, Locking Post,11mm
• 00854865007021: AdvantageRib Bridge, Long
• 00854865007014: AdvantageRib Bridge, Medium
• 00854865007007: AdvantageRib Bridge, Short
• 00854865007595: AdvantageRib Short Bridge and 23mm Locking Posts
• 00854865007588: AdvantageRib Short Bridge and 18mm Locking Posts
• 00854865007571: AdvantageRib Short Bridge and 11mm Locking Posts
• 00854865007564: AdvantageRib Short Bridge and 10mm Locking Posts
• 00854865007557: AdvantageRib Short Bridge and 23mm Locking Posts
• 00854865007540: AdvantageRib Short Bridge and 18mm Locking Posts
• 00854865007533: AdvantageRib Short Bridge and 11mm Locking Posts
• 00854865007526: AdvantageRib Short Bridge and 10mm Locking Posts
• 00854865007519: AdvantageRib Short Bridge and 23mm Locking Posts
• 00854865007502: AdvantageRib Short Bridge and 18mm Locking Posts
• 00854865007496: AdvantageRib Short Bridge and 11mm Locking Posts
• 00854865007489: AdvantageRib Short Bridge and 10mm Locking Posts