WR400-40-40

GUDID 00849771047353

Sterilization Wrap, 400 Weight, 40-inch x 40-inch, 90-day

KEY SURGICAL, INC.

Sterilization packaging, single-use

• Primary Device ID: 00849771047353
• NIH Device Record Key: 2fbcaec1-d6c3-4924-9d34-70df40e6cffe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: WR400-40-40
• Catalog Number: WR400-40-40
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 72
• 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: 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
• 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
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• Length: 22 Inch
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• 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
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• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771047353 [Unit of Use]
GS1	10849771047350 [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: 2022-04-18
• Device Publish Date: 2022-04-08

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