RSR-22-553

GUDID 08800046017626

GNI Co.,Ltd

Orthodontic bracket, ceramic

• Primary Device ID: 08800046017626
• NIH Device Record Key: cc32cff0-75a1-42d8-adc1-e1561756925c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RSR-22-553
• Version Model Number: RSR-22-553
• Company DUNS: 694828541
• Company Name: GNI 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: true
• Device Combination Product: false
• Single Use: true
• 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	08800046017626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182672

FDA Product Code

• NJM: Bracket, Ceramic, Orthodontic

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: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by GNI Co.,Ltd

• 08800046051309 - SSBC-M22-464G: 2024-06-26
• 08800046051316 - SSBC-M22-364G: 2024-06-26
• 08800046051323 - SSBC-M22-264G: 2024-06-26
• 08800046051330 - SSBC-M22-164G: 2024-06-26
• 08800046051385 - SSBC-M22-1M44G: 2024-06-26
• 08800046027540 - IES1-1001: 2024-06-12
• 08800046045896 - P01-01: 2024-06-12
• 08800046046602 - SN02-1018: 2024-06-12