BZ3100020-07

GUDID 00841379180623

EXPANDABLE INSERTER, INNER SHAFT ASSEMBLY, OFFSET

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: 00841379180623
• NIH Device Record Key: 5013335d-a9b4-45f7-bcfd-0f7ac7e91924
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BZ3100020-07
• Catalog Number: BZ3100020-07
• 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	00841379180623 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

Moist Heat or Steam Sterilization

[00841379180623]

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.

• 00840085257469 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257476 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257483 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257490 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257506 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257513 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257520 - NA: 2024-04-18 DUAL LEAD SCREW
• 00840085257537 - NA: 2024-04-18 DUAL LEAD SCREW