Drive Rail 21-0100

GUDID 00817867020382

Rail, 100mm

DEVISE ORTHO INC.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00817867020382
• NIH Device Record Key: 5028e0f9-0ef7-4564-8da5-4fe46dd01162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drive Rail
• Version Model Number: 21-0100
• Catalog Number: 21-0100
• Company DUNS: 080456972
• Company Name: DEVISE ORTHO 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: false
• 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: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com
• Phone: 901-748-2581
• Email: info@deviseortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817867020382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140822

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

Moist Heat or Steam Sterilization

[00817867020382]

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: 2016-12-13

On-Brand Devices [Drive Rail]

• 00817867020481: Rotating Carriage Locking Disk
• 00817867020474: Rotating Carriage
• 00817867020450: Clamp, Angle 2 Hole
• 00817867020443: Drive Shaft
• 00817867020436: Carriage, Rail Arch
• 00817867020429: Standard Carriage
• 00817867020412: Add-A-Rail, 100mm
• 00817867020405: Add-A-Rail, 50mm
• 00817867020399: Rail, 200mm
• 00817867020382: Rail, 100mm
• 00817867020375: Screw, 1/4-28 X 45mm
• 00817867020368: Screw, 1/4-28 X 29mm
• 00817867020351: Screw, 1/4-20 X 22mm
• 00817867020344: Screw, 1/4-28 X 13mm
• 00817867020337: Set Screw
• 00817867020320: Screw, Clamp To Carriage
• 00817867020313: Screw, Short, Clamp To Carriage
• 00817867020306: Hinge, Low Overhang +5mm
• 00817867020290: Hinge, High Overhang
• 00817867020283: Hinge, Low Overhang
• 00817867020276: Hinge, High Range
• 00817867020269: Hinge, Low Range
• 00817867020252: Post, 6 Hole
• 00817867020245: Post, 5 Hole
• 00817867020238: Post, 4 Hole
• 00817867020221: Post, 3 Hole
• 00817867020214: Post, 2 Hole
• 00817867020207: Post, 1 Hole
• 00817867020191: Clamp, 7 Hole Stacked (5, 2 Config)
• 00817867020184: Clamp, 5 Hole In-Line
• 00817867020177: Clamp, 5 Hole Stacked (4, 1 Config)
• 00817867020160: Clamp, 4 Hole In-Line
• 00817867020153: Clamp, 3 Hole In-Line
• 00817867020146: Clamp, 2 Hole In-Line
• 00817867020139: Clamp, 1 Hole
• 00817867020122: Drive Mechanism
• 00817867020115: Rail End Cap
• 00817867020108: Arch, 41 cm
• 00817867020092: Arch, 34 cm
• 00817867020085: Arch, 27 cm
• 00817867020078: Arch, 20 cm
• 00817867020061: Arch, 13 cm
• 00817867020054: Arch, 9 cm
• 00817867020047: Rail Hinge Mount/Rail Stop
• 00817867020030: Clamp Rotational Mount
• 00817867020023: Rail Rotational Mount
• 00817867020016: Arch Rotational Mount
• 00817867020511: Hinge, 0 to 7.5mm
• 00817867020504: Hinge, 12.5 to 20mm
• 00817867020498: Rotating Carriage Free Disk