SFIT Crown Gauge

GUDID 08800016117769

Cowellmedi Co.,Ltd

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08800016117769
• NIH Device Record Key: a6642864-aff1-4c62-a9e7-4764e02c866c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFIT Crown Gauge
• Version Model Number: SFCG
• Company DUNS: 688753763
• Company Name: Cowellmedi 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08800016117769 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by Cowellmedi Co.,Ltd

• 08800016163070 - Dental Instrument: 2026-02-06
• 08800016176841 - Dental Instrument: 2026-02-06
• 08800016176858 - Dental Instrument: 2026-02-06
• 08800016176865 - Dental Instrument: 2026-02-06
• 08800016101362 - Dental Instrument: 2026-02-05
• 08800016114256 - Dental Implants Accesseories-Single Use: 2026-02-05
• 08800016114447 - Dental Instrument: 2026-02-05
• 08800016114454 - Dental Instrument: 2026-02-05