Hammer Tech TN-TR-0007

GUDID 00852164007353

TI Tray

FUSION ORTHOPEDICS, LLC

Instrument tray, reusable

• Primary Device ID: 00852164007353
• NIH Device Record Key: c35bf891-b222-41d5-b876-690aaedca1e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hammer Tech
• Version Model Number: TN-TR-0007
• Catalog Number: TN-TR-0007
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: true
• 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	00852164007353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182684

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

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

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

[00852164007353]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-27
• Device Publish Date: 2025-05-19

On-Brand Devices [Hammer Tech]

• 00840124519046: Reusable HT Handle
• 00852164007353: TI Tray
• 00852164007346: PEEK Tray
• 00840124520868: 2X Tray
• 00840124520851: 2X Tray