Cytrans Granules 10007520

GUDID 04548161312175

Cytrans Granules M 2g 1pc. 231.00

Gc America Inc.

Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic

• Primary Device ID: 04548161312175
• NIH Device Record Key: 9b6038f6-2f3f-4a0c-933f-54a108c980a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytrans Granules
• Version Model Number: 10007520
• Catalog Number: 10007520
• 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
• 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
• 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	04548161312175 [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: 2022-04-11
• Device Publish Date: 2022-04-01

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.