HX0006 tracker Tray

GUDID 00860161000383

SURGICAL PLANNING ASSOC INC

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00860161000383
• NIH Device Record Key: 38e00c88-d1de-44ee-adc1-2c88d52a0c67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HX0006 tracker Tray
• Version Model Number: HX0006
• Company DUNS: 606309636
• Company Name: SURGICAL PLANNING ASSOC INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860161000383 [Primary]

Sterilization

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

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

[00860161000383]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-01-09

Devices Manufactured by SURGICAL PLANNING ASSOC INC

• 00860161000369 - HipXpert HXA0003B kit: 2023-05-03
• 00860161000383 - HX0006 tracker Tray: 2023-05-03
• 00860161000383 - HX0006 tracker Tray: 2023-05-03
• 00860161000352 - Hipxpert HX0002B: 2023-02-16
• 00860161000376 - HXA0005: 2022-11-03
• 00860161000338 - Hipxpert HX0004: 2022-10-19 Hipxpert/Insight Lateral kit with tracker tray Instrument System