C188

GUDID 50849771050655

Pin Covers, Sterile, Orange, 0.177-inch, 2 per package

KEY SURGICAL, INC.

Surgical instrument guard, single-use

• Primary Device ID: 50849771050655
• NIH Device Record Key: a016b103-342a-4548-b56c-409a0822700a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: K-Wire and Pin Covers
• Catalog Number: C188
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 2
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch
• Lumen/Inner Diameter: 0.177 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771000723 [Previous]
GS1	00849771050650 [Unit of Use]
GS1	10849771050657 [Primary]
GS1	50849771050655 [Package]; Contains: 10849771050657; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

[50849771050655]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-11
• Device Publish Date: 2024-10-03

Devices Manufactured by KEY SURGICAL, INC.

• 00849771046356 - K-Wire and Steinmann Pin Dispensers: 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 20
• 00849771046363 - K-Wire and Steinmann Pin Dispensers: 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22
• 00849771046370 - K-Wire and Steinmann Pin Dispensers: 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24
• 00849771046387 - K-Wire and Steinmann Pin Dispensers: 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25
• 00849771046394 - K-Wire and Steinmann Pin Dispensers: 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 26
• 00849771013372 - Key Surgical Cautery Tip Cleaner: 2025-04-14 Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
• 50849771050617 - NA: 2025-03-17 Pin Covers, Sterile, Tan, 2 per package
• 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.