IS33018

GUDID 00849771047582

Instrument Stringers, Surgical stainless steel, 18-inch x 3-inch

KEY SURGICAL, INC.

Sterilization stringer

• Primary Device ID: 00849771047582
• NIH Device Record Key: 480a810f-4992-48cf-8319-f0d26fa30083
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Instrument Stringers
• Catalog Number: IS33018
• 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: true
• 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 Dimensions

• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771013105 [Previous]
GS1	00849771047582 [Primary]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

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

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771047582]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by KEY SURGICAL, INC.

• 10724995225022 - Electro Lube: 2024-10-11 Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
• 00849771048190 - NA: 2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long
• 00849771052562 - Key Surgical Pipe Cleaners: 2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet
• 00849771050131 - NA: 2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long
• 50849771050563 - NA: 2024-10-11 K-Wire Covers, Sterile, White, 2 per package
• 50849771050624 - NA: 2024-10-11 Pin Covers, Sterile, Lavender, 2 per package
• 50849771050655 - NA: 2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package
• 00849771048503 - NA: 2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm