Site Prep Impactor

GUDID 00850040139594

SR12- ION Facet Screw System

SURGENTEC, LLC

Spinal bone screw, bioabsorbable

• Primary Device ID: 00850040139594
• NIH Device Record Key: 454101f0-5839-4148-876b-4ad0660bfa69
• Commercial Distribution Discontinuation: 2024-09-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Site Prep Impactor
• Version Model Number: SR12-6201
• 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	00850040139594 [Primary]

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

[00850040139594]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-20
• Device Publish Date: 2024-09-12

Devices Manufactured by SURGENTEC, LLC

• 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