Key Surgical K-Wires and Steinmann Pins

GUDID 00849771044963

K-Wires, Single diamond, round end, .045" (1.1mm) diameter, 9" long

KEY SURGICAL, INC.

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00849771044963
• NIH Device Record Key: ece0444c-9e9f-483c-b833-3ee1e4bdced3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Key Surgical K-Wires and Steinmann Pins
• Version Model Number: KI-71-242
• 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: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 800.541.7995
• Email: regulatory@keysurgical.com
• Phone: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00849771012849 [Primary]
GS1	00849771044963 [Unit of Use]

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

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

[00849771044963]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-30
• Device Publish Date: 2020-12-22

On-Brand Devices [Key Surgical K-Wires and Steinmann Pins]

• 00849771044222: K-Wire, Single Trocar, 1cm partially threaded, 0.049" (1.25mm) diameter, 5.90" (150mm) length
• 00849771044215: K-Wires, Double Blunt, .094" (2.4mm) diameter, 20" long
• 00849771044192: K-Wires, Single trocar, .062" (1.6mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
• 00849771044185: K-Wires, Single trocar, .054" (1.4mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
• 00849771044178: K-Wires, Single trocar, .045" (1.1mm) diameter, 6" long, ASTM A967, F138, S/S 1.4441
• 00849771044161: K-Wires, Single trocar, .035" (.9mm) diameter, 4" long, ASTM A967, F138, S/S 1.4441
• 00849771044208: K-Wires, Single trocar, .062" (1.6mm) diameter, 11" long
• 00849771044239: K-Wires, Double Blunt, .032" (0.81mm) diameter, 6" long
• 00849771044444: K-Wires, Double trocar, .028" (.7mm) diameter, 9" long
• 00849771044529: K-Wires, Double trocar, .054" (1.4mm) diameter, 12" long
• 00849771044512: K-Wires, Double trocar, .062" (1.6mm) diameter, 12" long
• 00849771044505: K-Wires, Double trocar, .045" (1.1mm) diameter, 12" long
• 00849771044499: K-Wires, Double trocar, .035" (.9mm) diameter, 12" long
• 00849771044482: K-Wires, Double trocar, .054" (1.4mm) diameter, 9" long
• 00849771044475: K-Wires, Double trocar, .062" (1.6mm) diameter, 9" long
• 00849771044468: K-Wires, Double trocar, .045" (1.1mm) diameter, 9" long
• 00849771044451: K-Wires, Double trocar, .035" (.9mm) diameter, 9" long
• 00849771044437: K-Wires, Double trocar, .062" (1.6mm) diameter, 5" long
• 00849771044420: K-Wires, Double trocar, .054" (1.4mm) diameter, 5" long
• 00849771044413: K-Wires, Double trocar, .045" (1.1mm) diameter, 5" long
• 00849771044406: K-Wires, Double trocar, .035" (.9mm) diameter, 5" long
• 00849771044390: K-Wires, Double trocar, .028" (.7mm) diameter, 5" long
• 00849771044383: K-Wires, Double trocar, .054" (1.4mm) diameter, 4" long
• 00849771044376: K-Wires, Double trocar, .062" (1.6mm) diameter, 4" long
• 00849771044369: K-Wires, Double trocar, .045" (1.1mm) diameter, 4" long
• 00849771044352: K-Wires, Double trocar, .035" (.9mm) diameter, 4" long
• 00849771044345: K-Wires, Double trocar, .028" (.7mm) diameter, 4" long
• 00849771044338: K-Wires, Double diamond, .054" (1.4mm) diameter, 6" long
• 00849771044321: K-Wires, Double diamond, .062" (1.6mm) diameter, 6" long
• 00849771044314: K-Wires, Double diamond, .045" (1.1mm) diameter, 6" long
• 00849771044307: K-Wires, Double diamond, .035" (.9mm) diameter, 6" long
• 00849771044291: K-Wires, Double diamond, .028" (.7mm) diameter, 6" long
• 00849771044284: K-Wires, Double trocar, .062" (1.6mm) diameter, 6" long
• 00849771044277: K-Wires, Double trocar, .054" (1.4mm) diameter, 6" long
• 00849771044260: K-Wires, Double trocar, .045" (1.1mm) diameter, 6" long
• 00849771044253: K-Wires, Double trocar, .035" (.9mm) diameter, 6" long
• 00849771044246: K-Wires, Double trocar, .028" (.7mm) diameter, 6" long
• 00849771045168: Steinmann Pins, Single Diamond, 4 Suture, 0.141" diameter, 12.0" long
• 00849771045151: Steinmann Pins, Double trocar threaded, 0.189" (4.8mm) diameter, 9" long
• 00849771045144: Steinmann Pins, Double trocar, 0.189" (4.8mm) diameter, 9" long
• 00849771045137: Steinmann Pins, Single trocar, round end, .188"diameter, 9" long
• 00849771045908: Steinmann Pins, Single Trocar with Round end, 3mm threaded, 9" (23cm) long, 0.093" (2.4mm) diam
• 00849771045892: Steinmann Pins, Single Trocar with Round end, 9" (23cm) long, 0.093" (2.4m) diam
• 00849771045120: K-Wires, Single Trocar with Round end, 9" (23cm) long, 0.051" (1.3mm) diam
• 00849771045113: K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.051" (1.3mm) diam
• 00849771045106: K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.039" (1.0mm) diam
• 00849771045090: K-Wires, Single Trocar with Round end, 6" (15cm) long, 0.028" (0.7mm) diam
• 00849771045571: Steinmann Pins, Single trocar, round end, 0.094" (2.4mm) diameter, 12" long
• 00849771044772: K-Wires, Single trocar, .045" (1.1mm) diameter, 6" long
• 00849771044741: K-Wires, Single trocar, .028" (.7mm) diameter, 6" long