KinematX

GUDID 00842078114612

KinematX Total Instrument Tray

EXTREMITY MEDICAL, LLC

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00842078114612
• NIH Device Record Key: 70344333-48f1-48ac-b78f-01abb4e5ade2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinematX
• Version Model Number: 137-00000
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078114612 [Primary]

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

[00842078114612]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-29

On-Brand Devices [KinematX]

• 00842078120019: Radial Body Assembly - RIGHT, +6
• 00842078120002: Radial Body Assembly - LEFT, +6
• 00842078119990: Radial Body Assembly - RIGHT, +4
• 00842078119983: Radial Body Assembly - LEFT, +4
• 00842078117033: 4.75 mm Locking Screw x 50
• 00842078117002: 4.75 mm Locking Screw x 45
• 00842078116999: 4.75 mm Locking Screw x 40
• 00842078116968: 4.75 mm Locking Screw x 35
• 00842078116937: 4.75 mm Locking Screw x 30
• 00842078116906: 4.75 mm Locking Screw x 25
• 00842078116876: 4.75 mm Locking Screw x 20
• 00842078116852: 4.75 mm Locking Screw x 15
• 00842078116838: Standard Baseplate, 15mm Stem
• 00842078116814: Standard Baseplate, 12mm Stem
• 00842078112090: Carpal Cap; Sterile Packed
• 00842078112045: Radial Body Assembly - RIGHT, +2
• 00842078112038: Radial Body Assembly - LEFT, +2
• 00842078112021: Radial Body Assembly - RIGHT, +0
• 00842078112014: Radial Body Assembly - LEFT, +0
• 00842078111536: KinematX Radial Stem - Size 3; Sterile Packed
• 00842078111529: KinematX Radial Stem - Size 2; Sterile Packed
• 00842078111512: KinematX Radial Stem - Size 1; Sterile Packed
• 00842078114612: KinematX Total Instrument Tray