JIZAI

GUDID 14546951616653

MANI NiTi FILES

MANI, INC.

Rotary/reciprocating endodontic file/rasp, reusable

• Primary Device ID: 14546951616653
• NIH Device Record Key: fedb39ab-796b-4d53-aa35-c9e2be2ec907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JIZAI
• Version Model Number: 025 14(18mm)/025 04,025 06(21mm)
• Company DUNS: 690622428
• Company Name: MANI, INC.
• Device Count: 3
• 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	04546951616656 [Primary]
GS1	14546951616653 [Package]; Contains: 04546951616656; Package: [1 Units]; In Commercial Distribution
GS1	74546951616655 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

[14546951616653]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-31
• Device Publish Date: 2025-01-23

On-Brand Devices [JIZAI]

• 14546951618411: MANI NiTi FILES
• 14546951618404: MANI NiTi FILES
• 14546951618398: MANI NiTi FILES
• 14546951618381: MANI NiTi FILES
• 14546951618312: MANI NiTi FILES
• 14546951618305: MANI NiTi FILES
• 14546951618299: MANI NiTi FILES
• 14546951618282: MANI NiTi FILES
• 14546951618275: MANI NiTi FILES
• 14546951618268: MANI NiTi FILES
• 14546951618251: MANI NiTi FILES
• 14546951618244: MANI NiTi FILES
• 14546951618237: MANI NiTi FILES
• 14546951618220: MANI NiTi FILES
• 14546951618213: MANI NiTi FILES
• 14546951618206: MANI NiTi FILES
• 14546951616752: MANI NiTi FILES
• 14546951616745: MANI NiTi FILES
• 14546951616660: MANI NiTi FILES
• 14546951616653: MANI NiTi FILES