PW4VM12

GUDID 60849771042220

Instrument Tray 8-3/4 X 4-5/8 X 3-1/8 Inch

KEY SURGICAL, INC.

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• Primary Device ID: 60849771042220
• NIH Device Record Key: 7cb108b9-b2e7-4f7c-953d-3ceb7243d5b5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PW4VM12
• Catalog Number: PW4VM12
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 12
• 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: false
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00849771042228 [Primary]
GS1	60849771042220 [Unit of Use]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by KEY SURGICAL, INC.

• 00849771047643 - NA: 2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch
• 00849771048077 - NA: 2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium
• 00849771048220 - NA: 2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long
• 00849771048244 - NA: 2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long
• 10849771050473 - NA: 2024-04-01 Suture Booties, White, Sterile, 5 pair per pad
• 00849771051275 - NA: 2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing
• 00849771051534 - Key Surgical Endoscope Brushes: 2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead
• 00849771051619 - Key Surgical Endoscope Brushes: 2024-04-01 Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered diameter