VL201

GUDID 10849771050541

Vascular Loops, Sterile, Red, Mini, 2 per package

KEY SURGICAL, INC.

Surgical vessel loop

• Primary Device ID: 10849771050541
• NIH Device Record Key: 0d51aa98-4358-4a5d-80c3-b6e38eea8e16
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Vascular Loops
• Catalog Number: VL201
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 1
• 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: 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

• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Length: 18 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771030836 [Previous]
GS1	00849771050544 [Primary]
GS1	10849771050541 [Package]; Contains: 00849771050544; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896676

FDA Product Code

• KDC: INSTRUMENT, SURGICAL, DISPOSABLE

Sterilization

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

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.

• 00849771048169 - NA: 2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long
• 00849771049012 - NA: 2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long
• 00849771049128 - NA: 2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long
• 60849771050416 - Electro Lube: 2025-05-02 Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
• 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