BZ4000000

GUDID 00840085242243

EXPANDABLE INSERTER, SIMPLIFIED

HYHTE HOLDINGS, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00840085242243
• NIH Device Record Key: 1e861e14-580d-4162-aed3-aa25981a353c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BZ4000000
• Catalog Number: BZ4000000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085242243 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

[00840085242243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-11
• Device Publish Date: 2021-08-03

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085265105 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265112 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265129 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265136 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265143 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265150 - NA: 2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085257469 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257476 - NA: 2024-04-18 DUAL LEAD SCREW