ChronOS 71000398S

GUDID H98071000398S0

CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/2.5CC-STERILE

SYNTHES (U.S.A.) LP

Bone matrix implant, synthetic

• Primary Device ID: H98071000398S0
• NIH Device Record Key: 513dede9-202b-4250-b487-164e22f994be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChronOS
• Version Model Number: 710.003.98S
• Catalog Number: 71000398S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587060774 [Primary]
HIBCC	H98071000398S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041350

FDA Product Code

• LPK: Bone grafting material, for dental bone repair

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [ChronOS]

• H98071005798S0: CHRONOS(TM) BETA-TCP WEDGE 7 DEG/SEMI-CIRCULAR-STERILE
• H98071005098S0: CHRONOS(TM) BETA-TCP WEDGE 10 DEG/RECTANGULAR-STERILE
• H98071004798S0: CHRONOS(TM) BETA-TCP BLOCK 20MM X 20MM X 10MM-STERILE
• H98071004298S0: CHRONOS(TM) BETA-TCP BLOCK 5MM X 5MM X 10MM-STERILE
• H98071001498S0: CHRONOS(TM) BETA-TCP GRANULES 1.4-2.8MM/5.0CC-STERILE
• H98071001198S0: CHRONOS(TM) BETA-TCP GRANULES 1.4-2.8MM/2.5CC-STERILE
• H98071000398S0: CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/2.5CC-STERILE
• H98071000298S0: CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/1.0CC-STERILE
• H98071000198S0: CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/0.5CC-STERILE
• H98071000098S0: CHRONOS(TM) BETA-TCP GRANULES 0.5-0.7MM/0.5CC-STERILE