AMDT Mini-Rail M708

GUDID 00850030203748

Rail, 50mm

Amdt Holdings, Inc.

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

• Primary Device ID: 00850030203748
• NIH Device Record Key: 0f9ff1a8-f6cf-4238-af15-a85d0a9282d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMDT Mini-Rail
• Version Model Number: 1
• Catalog Number: M708
• Company DUNS: 117990191
• Company Name: Amdt Holdings, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com
• Phone: 901-853-4366
• Email: INFO@AMDTHoldings.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030203748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162032

FDA Product Code

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

Sterilization

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

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

[00850030203748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [AMDT Mini-Rail]

• 00850030203915: Collet, 3.0mm
• 00850030203908: Collet, 2.0mm
• 00850030203892: Collet, 1.6mm
• 00850030203885: Threaded Wire, ø2.0mm, 15mm thread, 125mm long
• 00850030203878: Threaded Wire, ø1.6mm, 15mm thread, 125mm long
• 00850030203847: Bone Screw ø3.0 mm X 100mm long, 40mm thread
• 00850030203830: Bone Screw ø3.0 mm X 100mm long, 30mm thread
• 00850030203823: Bone Screw ø3.0 mm X 80mm long, 25mm thread
• 00850030203816: Bone Screw ø3.0 mm X 80mm long, 30mm thread
• 00850030203809: Bone Screw ø3.0 mm X 60mm long, 25mm thread
• 00850030203793: Bone Screw ø3.0 mm X 100mm long, 20mm thread
• 00850030203786: Bone Screw ø3.0 mm X 60mm long, 20mm thread
• 00850030203779: Rail, 150mm
• 00850030203762: Rail, 100mm
• 00850030203755: Rail, 75mm
• 00850030203748: Rail, 50mm
• 00850030203731: End Clamp, Standard 90°
• 00850030203724: End Clamp, Standard In-line
• 00850030203717: End Clamp, Universal
• 00850030203700: Traveling Clamp, Standard Clutched
• 00850030203694: Traveling Clamp, Universal Clutched