KI71750

GUDID 00849771050148

Steinmann Pins, Double trocar threaded, 5/64-inch (2.0mm) diameter, 9-inch (22.86cm) long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00849771050148
• NIH Device Record Key: a8736903-0bae-47aa-b544-9255e336a528
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: K-Wires and Steinmann Pin
• Catalog Number: KI71750
• 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
• 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
• 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
• Phone: +1(800)541-7995
• Email: regulatory@keysurgical.com

Device Dimensions

• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 22.86 Centimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771015499 [Previous]
GS1	00849771050148 [Unit of Use]
GS1	10849771050145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102845

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

[00849771050148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-14
• Device Publish Date: 2023-01-26

Devices Manufactured by KEY SURGICAL, INC.

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• 00849771048077 - NA: 2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium
• 00849771048220 - NA: 2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long
• 00849771048244 - NA: 2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long
• 10849771050473 - NA: 2024-04-01 Suture Booties, White, Sterile, 5 pair per pad
• 00849771051275 - NA: 2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing
• 00849771051534 - Key Surgical Endoscope Brushes: 2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead
• 00849771051619 - Key Surgical Endoscope Brushes: 2024-04-01 Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered diameter