GZC01C16B

GUDID 00840085208485

LLIF IMPLANT TRIAL, MODULAR, STRAIGHT

HYHTE HOLDINGS, INC.

Spinal implant trial

• Primary Device ID: 00840085208485
• NIH Device Record Key: 546649b5-6b38-44b1-b214-f2b66d50e6b9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GZC01C16B
• Catalog Number: GZC01C16B
• 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
• 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 Dimensions

• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree
• Width: 22 Millimeter
• Height: 16 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085208485 [Primary]

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

[00840085208485]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085271861 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE AWL
• 00840085271878 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT
• 00840085271885 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED
• 00840085271892 - NA: 2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT
• 00840085271908 - NA: 2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED
• 00840085271915 - NA: 2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM
• 00840085271922 - NA: 2025-03-06 EGPS, CORTICAL, TAP, 3.5MM
• 00840085271939 - NA: 2025-03-06 EGPS, CORTICAL, TAP, 4.0MM