GraftRasp Sterilization Tray

GUDID 00858406007631

SURGENTEC, LLC

Bone file/rasp, manual, single-use

• Primary Device ID: 00858406007631
• NIH Device Record Key: 672277f4-aae1-4ed5-a022-cda9aef59c67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GraftRasp Sterilization Tray
• Version Model Number: SR10-7020
• 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	00858406007631 [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

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

Moist Heat or Steam Sterilization

[00858406007631]

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

Devices Manufactured by SURGENTEC, LLC

• 00858406007259 - 6mm Dilator: 2024-12-26
• 00858406007266 - 10mm Dilator: 2024-12-26
• 00858406007273 - 17mm Dilator: 2024-12-26
• 00858406007280 - 20mm Dilator: 2024-12-26
• 00858406007532 - 13mm Dilator: 2024-12-26
• 00858406007631 - GraftRasp Sterilization Tray: 2024-12-26
• 00858406007631 - GraftRasp Sterilization Tray: 2024-12-26
• 00858406007716 - 3/4 inch Cobb: 2024-12-26
• 00810131880910 - Guide Pin - Bevel: 2024-12-17