LZA100000

GUDID 00840085242458

FULL PLATE INSERTER

HYHTE HOLDINGS, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00840085242458
• NIH Device Record Key: 398e64ec-4e41-4751-b78d-c1acd121cb47
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LZA100000
• Catalog Number: LZA100000
• 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: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085242458 [Primary]

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

[00840085242458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2021-07-27

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00841379176572 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176589 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176596 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176602 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176619 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176626 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176633 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176657 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING