Midwest 45 FBE NFO

GUDID 04548213745043

J.MORITA MFG.CORP.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04548213745043
• NIH Device Record Key: 2b639b55-769c-4c33-b1cd-37ea32340e28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midwest 45 FBE NFO
• Version Model Number: 745044
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• 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: false
• Serial Number: true
• 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	04548213745043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061701

FDA Product Code

• EFA: Handpiece, Belt And/Or Gear Driven, Dental

Sterilization

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

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

[04548213745043]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-28
• Device Publish Date: 2023-08-18

Devices Manufactured by J.MORITA MFG.CORP.

• 04548213745043 - Midwest 45 FBE NFO: 2023-08-28
• 04548213745043 - Midwest 45 FBE NFO: 2023-08-28
• 04548213745241 - Midwest 45 K-Style NFO: 2023-08-28
• 04548213056538 - Root ZX3: 2023-07-05
• 04548213056545 - Root ZX3: 2023-07-05
• 04548213055999 - J. MORITA MFG. CORP.: 2023-03-14 Revised version of TR-ZX2 from 2023.
• 04548213027408 - J. MORITA MFG. CORP.: 2023-02-09 Attachments for Air and Electric Motors
• 04548213053261 - Veraview FX800: 2021-07-23
• 04548213016341 - 3D Accuitomo XYZ Slice View Tomograph: 2020-03-30