wenjian

GUDID 16972249850320

Foshan Wenjian Medical Instrument Co., Ltd.

Dental power tool system handpiece, pneumatic

• Primary Device ID: 16972249850320
• NIH Device Record Key: 0b8ea3d3-a8a9-4077-85c4-0fa67d3034c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: wenjian
• Version Model Number: WJ-162
• Company DUNS: 543064035
• Company Name: Foshan Wenjian Medical Instrument Co., Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972249850323 [Primary]
GS1	16972249850320 [Package]; Contains: 06972249850323; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181691

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

[16972249850320]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-05
• Device Publish Date: 2021-03-26

On-Brand Devices [wenjian]

• 16972249850382: WJ-422
• 16972249850375: WJ-424
• 16972249850368: WJ-412
• 16972249850337: WJ-414
• 16972249850320: WJ-162
• 16972249850313: WJ-164
• 16972249850306: WJ-152
• 16972249850290: WJ-154
• 16972249850283: WJ-142
• 16972249850276: WJ-144
• 16972249850269: WJ-132
• 16972249850252: WJ-134
• 16972249850245: WJ-122
• 16972249850238: WJ-124
• 16972249850221: WJ-112
• 16972249850214: WJ-114