AOS TIBIAL NAIL 8mm x 39.0cm

GUDID 00848665015997

ADVANCED ORTHOPEDIC SOLUTIONS INC

Tibia nail, non-sterile

• Primary Device ID: 00848665015997
• NIH Device Record Key: 106aa614-a61f-40f3-8b57-c6bddf1d13a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS TIBIAL NAIL 8mm x 39.0cm
• Version Model Number: 1108-390
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• 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: true
• Donation Id Number: false
• 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	00848665015997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070444

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00848665015997]

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: 2015-10-23

On-Brand Devices [AOS TIBIAL NAIL 8mm x 39.0cm]

• 00848665015997: 1108-390
• 00848665005059: S1108-390