Decortication Rasp - Fixed Curved

GUDID 00858406007358

SURGENTEC, LLC

Bone file/rasp, manual, reusable

• Primary Device ID: 00858406007358
• NIH Device Record Key: 1fbb281a-465b-468f-b0e4-ff012b1793cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Decortication Rasp - Fixed Curved
• Version Model Number: 3D-D05-03
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858406007358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201900

FDA Product Code

• HTR: Rasp

Sterilization

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

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

[00858406007358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-04
• Device Publish Date: 2025-01-27

Devices Manufactured by SURGENTEC, LLC

• 00858406007358 - Decortication Rasp - Fixed Curved: 2025-02-04
• 00858406007358 - Decortication Rasp - Fixed Curved: 2025-02-04
• 00810131880798 - Spinous Process Plate, 8mm: 2025-01-13
• 00810131880804 - Spinous Process Plate, 10mm: 2025-01-13
• 00810131880811 - Spinous Process Plate, 12mm: 2025-01-13
• 00810131880828 - Spinous Process Plate, 14mm: 2025-01-13
• 00810131880835 - Spinous Process Plate, 16mm: 2025-01-13
• 00810131881047 - BMAC Bevel Needle Assembly: 2025-01-13
• 00810131881054 - BMAC Bevel Needle Pouched: 2025-01-13