WR500-48-48

GUDID 00849771047131

Bonded Sterilization Wrap, 500 Weight, 48-inch x 48-inch

KEY SURGICAL, INC.

Sterilization packaging, single-use

• Primary Device ID: 00849771047131
• NIH Device Record Key: 65841f4c-4004-4d4e-8886-303781297594
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: WR500-48-48
• Catalog Number: WR500-48-48
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 48
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Device Dimensions

• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch
• Width: 18 Inch
• Length: 22 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771047131 [Unit of Use]
GS1	10849771047138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160755

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

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