Cytrans Granules 014363

GUDID 14548161312165

Cytrans Granules M 0.5g 1pc.

Gc America Inc.

Dental bone matrix implant, synthetic

• Primary Device ID: 14548161312165
• NIH Device Record Key: 3e267b23-07cb-4e1e-9ac8-3334146c7119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytrans Granules
• Version Model Number: 014363
• Catalog Number: 014363
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161312165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192597

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [Cytrans Granules]

• D0470143641: Cytrans Granules M 2g 1pc. 231.00
• D0470143631: Cytrans Granules M 0.5g 1pc.
• D0470143621: Cytrans Granules S 0.5g 1pc.
• D0470143611: Cytrans Granules M 0.25g 1pc.
• D0470143601: Cytrans Granules S 0.25g 1pc.
• 04548161312175: Cytrans Granules M 2g 1pc. 231.00
• 04548161312168: Cytrans Granules M 0.5g 1pc.
• 04548161312151: Cytrans Granules S 0.5g 1pc.
• 04548161312144: Cytrans Granules M 0.25g 1pc.
• 04548161312137: Cytrans Granules S 0.25g 1pc.
• 14548161312172: Cytrans Granules M 2g 1pc. 231.00
• 14548161312165: Cytrans Granules M 0.5g 1pc.
• 14548161312158: Cytrans Granules S 0.5g 1pc.
• 14548161312141: Cytrans Granules M 0.25g 1pc.
• 14548161312134: Cytrans Granules S 0.25g 1pc.