KI71206

GUDID 00849771049364

K-Wires, Double diamond, .035-inch (.9mm) diameter, 5-inch long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00849771049364
• NIH Device Record Key: 6d396d5c-755b-484e-98c9-2ed3ec973398
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: K-Wires and Steinmann Pins
• Catalog Number: KI71206
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 6
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771012740 [Previous]
GS1	00849771049364 [Unit of Use]
GS1	10849771049361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102845

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

[00849771049364]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-01
• Device Publish Date: 2024-03-22

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