RSR-22-553

GUDID 08800046017626

GNI Co.,Ltd

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic 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