Site Prep Barbed Guide

GUDID 00850040139433

SURGENTEC, LLC

Bone marrow biopsy procedure kit

• Primary Device ID: 00850040139433
• NIH Device Record Key: f7cc7fd1-6e99-4733-9f29-1c06e72f6e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Site Prep Barbed Guide
• Version Model Number: SR07-6020
• 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: true
• 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	00850040139433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240664

FDA Product Code

• PDQ: Neurosurgical Nerve Locator

Sterilization

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

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

[00850040139433]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [ Site Prep Barbed Guide]

• 00850040139600: SR12- ION Facet Screw System
• 00850040139433: SR07-6020