Osstem Implant Co.,Ltd.

GUDID 08800000995649

This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It consists of a camera head, a battery, a charging cradle, and a receiver module. Investigate the light from the mouth LED to capture the image from the camera module and wirelessly transmit the data via UWB. Additionally, the transmitted image can be viewed using a separate viewer program on the PC ti which the receiver module is connected.

Osstem Implant Co.,Ltd.

Intraoral camera

• Primary Device ID: 08800000995649
• NIH Device Record Key: 7b3daecc-8d12-4777-b04f-306f983b5ebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osstem Implant Co.,Ltd.
• Version Model Number: SNAP Wireless
• Company DUNS: 694893867
• Company Name: Osstem Implant Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• 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: 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	08800000995649 [Primary]

FDA Product Code

• QJK: Intraoral Camera

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

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