MICRO FILES TYPE UD Single

GUDID 74546951635823

MANI MICRO FILES TYPE U

MANI, INC.

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

• Primary Device ID: 74546951635823
• NIH Device Record Key: 4be095c2-bf36-46cb-9aaa-d2558ee1fd84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICRO FILES TYPE UD Single
• Version Model Number: TYPE UD Single #3-F
• Company DUNS: 690622428
• Company Name: MANI, INC.
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546951635824 [Primary]
GS1	74546951635823 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

[74546951635823]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by MANI, INC.

• 74546951616990 - MANI SURGICAL BURS: 2025-12-18 MANI CARBIDE BURS
• 74546951617003 - MANI SURGICAL BURS: 2025-12-18 MANI CARBIDE BURS
• 74546951617010 - MANI SURGICAL BURS: 2025-12-18 MANI CARBIDE BURS
• 74546951635823 - MICRO FILES TYPE UD Single: 2025-12-18MANI MICRO FILES TYPE U
• 74546951635823 - MICRO FILES TYPE UD Single: 2025-12-18 MANI MICRO FILES TYPE U
• 74546951635830 - MICRO FILES TYPE UD Double: 2025-12-18 MANI MICRO FILES TYPE U
• 74546951635847 - MICRO FILES TYPE UE Single: 2025-12-18 MANI MICRO FILES TYPE U
• 74546951635854 - MICRO FILES TYPE UE Double: 2025-12-18 MANI MICRO FILES TYPE U
• 14546951617063 - JIZAI: 2025-03-25 MANI NiTi FILES R