EK III NH Fixture No Mount

GUDID 00810019244902

HIOSSEN, INC.

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• Primary Device ID: 00810019244902
• NIH Device Record Key: 96ba806a-4c1c-47cc-92af-7b02fb011371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK III NH Fixture No Mount
• Version Model Number: CEK3S4013B
• Company DUNS: 796083090
• Company Name: HIOSSEN, 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00810019244902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203360

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: 2022-01-21
• Device Publish Date: 2022-01-13

On-Brand Devices [EK III NH Fixture No Mount]

• 00810019245008: CEK3S5013B
• 00810019244995: CEK3S5011B
• 00810019244988: CEK3S5010B
• 00810019244971: CEK3S5008B
• 00810019244964: CEK3S5007B
• 00810019244957: CEK3S4513B
• 00810019244940: CEK3S4511B
• 00810019244933: CEK3S4510B
• 00810019244926: CEK3S4508B
• 00810019244919: CEK3S4507B
• 00810019244902: CEK3S4013B
• 00810019244896: CEK3S4011B
• 00810019244889: CEK3S4010B
• 00810019244872: CEK3S4008B
• 00810019244865: CEK3S4007B
• 00810019244858: CEK3S3513B
• 00810019244841: CEK3S3511B
• 00810019244827: CEK3S3508B
• 00810019244834: CEK3S3510B
• 00810125997396: CEK3S7013B
• 00810125997389: CEK3S7011B
• 00810125997372: CEK3S7010B
• 00810125997365: CEK3S7008B
• 00810125997358: CEK3S7007B
• 00810125997341: CEK3S7006B
• 00810125997334: CEK3S6013B
• 00810125997327: CEK3S6011B
• 00810125997310: CEK3S6010B
• 00810125997303: CEK3S6008B
• 00810125997297: CEK3S6007B
• 00810125997280: CEK3S6006B
• 00810125997273: CEK3S5513B
• 00810125997266: CEK3S5511B
• 00810125997259: CEK3S5510B
• 00810125997242: CEK3S5508B
• 00810125997235: CEK3S5507B
• 00810125997228: CEK3S3013B
• 00810125997211: CEK3S3011B
• 00810125997204: CEK3S3010B
• 00810125997198: CEK3S3008B
• 00810125997181: CEK3S3007B