IS12512

GUDID 00849771052166

Instrument Stringers, stainless steel, 12-inch x 2.5-inch

KEY SURGICAL, INC.

Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer Sterilization stringer

• Primary Device ID: 00849771052166
• NIH Device Record Key: 75bf19f0-2dcc-4742-bcb9-e7be4c493f4b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Instrument Stringers
• Catalog Number: IS12512
• Company DUNS: 604056226
• Company Name: KEY SURGICAL, INC.
• Device Count: 1
• 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: true
• 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

Device Dimensions

• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849771038450 [Previous]
GS1	00849771052166 [Primary]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

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

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00849771052166]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

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