RC1001280

GUDID 00840085269189

SI SCREW, FIXED, COMPRESSION THREAD, ASTURACOAT FINISH

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840085269189
• NIH Device Record Key: 940f3ae2-1b76-4a0c-a8cd-052158cd994c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RC1001280
• Catalog Number: RC1001280
• 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
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085269189 [Primary]

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-02-13

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085272509 - NA: 2024-11-06 ENDPLATE, 20MM, VARIABLE LORDISIS, LATERAL, FULL, R.
• 00840085273322 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273339 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273346 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273353 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273360 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273377 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273384 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.