CORE1 Fixture Set

GUDID 08800023100020

Cybermed Inc.

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• Primary Device ID: 08800023100020
• NIH Device Record Key: 9b7cb61f-3653-4d20-8cd3-8613774b66b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE1 Fixture Set
• Version Model Number: C1M3010C
• Company DUNS: 688248447
• Company Name: Cybermed Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwa95@cybermed.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023100020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210039

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [CORE1 Fixture Set]

• 08800023100457: C1M3511OC
• 08800023100563: C1R4513OC
• 08800023100556: C1R4511OC
• 08800023100549: C1R4510OC
• 08800023100532: C1R4508OC
• 08800023100525: C1R4507OC
• 08800023100518: C1R4013OC
• 08800023100501: C1R4011OC
• 08800023100495: C1R4010OC
• 08800023100488: C1R4008OC
• 08800023100471: C1R4007OC
• 08800023100464: C1M3513OC
• 08800023100440: C1M3510OC
• 08800023100433: C1M3508OC
• 08800023100327: C1R5013C
• 08800023100310: C1R5011C
• 08800023100303: C1R5010C
• 08800023100297: C1R5008C
• 08800023100280: C1R5007C
• 08800023100273: C1R4513C
• 08800023100266: C1R4511C
• 08800023100259: C1R4510C
• 08800023100242: C1R4508C
• 08800023100235: C1R4507C
• 08800023100228: C1R4013C
• 08800023100211: C1R4011C
• 08800023100204: C1R4010C
• 08800023100198: C1R4008C
• 08800023100181: C1R4007C
• 08800023100174: C1R4013SC
• 08800023100167: C1R4011SC
• 08800023100150: C1R4010SC
• 08800023100143: C1R4008SC
• 08800023100136: C1R4007SC
• 08800023100129: C1M3513C
• 08800023100112: C1M3511C
• 08800023100105: C1M3510C
• 08800023100099: C1M3508C
• 08800023100082: C1M3513SC
• 08800023100075: C1M3511SC
• 08800023100051: C1M3508SC
• 08800023100044: C1M3013C
• 08800023100037: C1M3011C
• 08800023100020: C1M3010C
• 08800023100013: C1M3008C