MT8500

GUDID 00849771048503

Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm

KEY SURGICAL, INC.

Instrument tray, reusable

• Primary Device ID: 00849771048503
• NIH Device Record Key: 623c0d13-d26d-4550-b162-457c3c708a08
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Instrument Tray
• Catalog Number: MT8500
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771005377 [Previous]
GS1	00849771048503 [Primary]

FDA Product Code

• LRP: TRAY, SURGICAL

Sterilization

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

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

[00849771048503]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-30
• Device Publish Date: 2024-08-22

Devices Manufactured by KEY SURGICAL, INC.

• 00849771048503 - NA: 2024-08-30Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm
• 00849771048503 - NA: 2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm
• 00849771052180 - Instrument Stringers: 2024-08-30 Instrument Stringer, U-Shaped Stringer, Surgical Stainless Steel, 16-inch x 2.75-inch
• 00849771050162 - NA: 2024-08-30 Steinmann Pins, Double trocar threaded, 7/64-inch (2.8mm) diameter, 9-inch long
• 10849771050466 - NA: 2024-08-09 Suture Booties, Red, Sterile, 5 pair per pad
• 50849771050631 - NA: 2024-08-09 Pin Covers, Sterile, Brown, 2 per package
• 50849771050846 - NA: 2024-08-09 Vascular Loops, Sterile, Blue, Super Maxi, 18-inch long, 2 per package
• 60849771028132 - NA: 2024-07-24 Polypropylene Channel Brush BLUE 16 INCH L 0.039 INCH DIAMETER
• 60849771028149 - NA: 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.039 INCH DIAMETER