OsteoMed 220-0643-54

GUDID 00845694088589

220-0103, Purple ID Tag, 1.6 16STP DL

OSTEOMED LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00845694088589
• NIH Device Record Key: a81387a6-0f48-4b4f-8988-4c040c067c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoMed
• Version Model Number: 220-0643-54
• Catalog Number: 220-0643-54
• Company DUNS: 606417780
• Company Name: OSTEOMED LLC
• Device Count: 1
• DM Exempt: true
• 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: 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: +1(800)456-7779
• Email: Customer.Service@osteomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845694088589 [Primary]

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[00845694088589]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-22

On-Brand Devices [OsteoMed]

• 00845694098434: Cannulated Non-Slip Screwdriver Body, 6.5/7.3mm
• 00845694098427: 14H Distal Fibula Plate, Right
• 00845694098410: 13H Distal Fibula Plate, Right
• 00845694098403: 12H Distal Fibula Plate, Right
• 00845694098397: 11H Distal Fibula Plate, Right
• 00845694098380: 10H Distal Fibula Plate, Right
• 00845694098373: 9H Distal Fibula Plate, Right
• 00845694098366: 8H Distal Fibula Plate, Right
• 00845694098359: 7H Distal Fibula Plate, Right
• 00845694098342: 6H Distal Fibula Plate, Right
• 00845694098335: 5H Distal Fibula Plate, Right
• 00845694098328: 4H Distal Fibula Plate, Right
• 00845694098311: 3H Distal Fibula Plate, Right
• 00845694098304: 2H Distal Fibula Plate, Right
• 00845694098298: 14H Distal Fibula Plate, Left
• 00845694098281: 13H Distal Fibula Plate, Left
• 00845694098274: 12H Distal Fibula Plate, Left
• 00845694098267: 11H Distal Fibula Plate, Left
• 00845694098250: 10H Distal Fibula Plate, Left
• 00845694098243: 9H Distal Fibula Plate, Left
• 00845694098236: 8H Distal Fibula Plate, Left
• 00845694098229: 7H Distal Fibula Plate, Left
• 00845694098212: 6H Distal Fibula Plate, Left
• 00845694098205: 5H Distal Fibula Plate, Left
• 00845694098199: 4H Distal Fibula Plate, Left
• 00845694098182: 3H Distal Fibula Plate, Left
• 00845694098175: 2H Distal Fibula Plate, Left
• 00845694098168: Periosteal Elevator, 3mm Round Edge
• 00845694098151: Periosteal Elevator, 3mm Straight Edge
• 00845694098144: 3.5/4.0 Medial Column Fusion Plate, Long
• 00845694098137: 3.5/4.0 Medial Column Fusion Plate, Medium
• 00845694098120: 3.5/4.0 Medial Column Fusion Plate, Short
• 00845694098113: 1.6mm Driver Stem w/ Post, Medium
• 00845694098106: 1.9mm x 4mm Safety Screw, PC
• 00845694098090: 1.6mm X 5mm Auto-Drive Screw, PC
• 00845694098083: 1.6mm X 4mm Auto-Drive Screw, PC
• 00845694098076: 1.6mm X 3.5mm Auto-Drive Screw, PC
• 00845694098069: Rigid Sterilization Container, LG
• 00845694098052: Sterilization Container, 2 BPS
• 00845694098045: Sterilization Container, 1 BPS
• 00845694098038: Replacement Battery, Sterile, 2-Pack
• 00845694098021: Replacement Battery, Sterile
• 00845694098014: Pinnacle Battery Power Screw Driver
• 00845694098007: 2.7mm x 40mm Variable Angle Locking Screw, Sterile, Qty 5
• 00845694097994: 2.7mm x 40mm Variable Angle Locking Screw, Sterile, Qty 2
• 00845694097987: 2.7mm x 38mm Variable Angle Locking Screw, Sterile, Qty 5
• 00845694097970: 2.7mm x 38mm Variable Angle Locking Screw, Sterile, Qty 2
• 00845694097963: 2.7mm x 36mm Variable Angle Locking Screw, Sterile, Qty 5
• 00845694097956: 2.7mm x 36mm Variable Angle Locking Screw, Sterile, Qty 2
• 00845694097949: 2.7mm x 34mm Variable Angle Locking Screw, Sterile, Qty 5