6mm Dilator

GUDID 00858406007259

SURGENTEC, LLC

Bone file/rasp, manual, single-use

• Primary Device ID: 00858406007259
• NIH Device Record Key: 00d8c5c1-61c4-4c7b-9388-294e16f552e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6mm Dilator
• Version Model Number: SR10-6015
• 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: false
• 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	00858406007259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200431

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

[00858406007259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

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• 00858406007785 - Narrow Rectangular Access Tip Adapter: 2025-03-24
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