TZBB20002

GUDID 00840085272653

IMPLANT ASSEMBLY GUIDE, BOTTOM, 16MM

HYHTE HOLDINGS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00840085272653
• NIH Device Record Key: a89e9388-1e84-48f8-8a6a-fb58d2f7e942
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TZBB20002
• Catalog Number: TZBB20002
• Company DUNS: 073029645
• Company Name: HYHTE HOLDINGS, 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: 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

Customer Support Contacts

• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085272653 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

[00840085272653]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-31
• Device Publish Date: 2024-10-23

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085272509 - NA: 2024-11-06 ENDPLATE, 20MM, VARIABLE LORDISIS, LATERAL, FULL, R.
• 00840085273322 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273339 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273346 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273353 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273360 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273377 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273384 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.