BH113007B

GUDID 00841379181286

OTLIF SPACER, EXPANDABLE, NON-STERILE

HYHTE HOLDINGS, INC.

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• Primary Device ID: 00841379181286
• NIH Device Record Key: a8d0922a-d7b7-4706-9c1a-2de1ef5acbf0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BH113007B
• Catalog Number: BH113007B
• 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 Dimensions

• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter
• Length: 30 Millimeter
• Height: 10.5 Millimeter
• Angle: 2 degree
• Width: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379181286 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

Moist Heat or Steam Sterilization

[00841379181286]

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.

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• 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