BH112612E

GUDID 00841379181064

OTLIF SPACER, EXPANDABLE, NON-STERILE

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00841379181064
• NIH Device Record Key: 1a208ca2-fb6c-4491-9dca-7a91e401fcc6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BH112612E
• Catalog Number: BH112612E
• 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

• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree
• Width: 11 Millimeter
• Length: 26 Millimeter
• Height: 17 Millimeter
• Angle: 15 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379181064 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

Moist Heat or Steam Sterilization

[00841379181064]

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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• 00840085265501 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265518 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265525 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265532 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265549 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265556 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW