ESSET KIT

GUDID 08809892339845

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08809892339845
• NIH Device Record Key: 46e8f584-3a69-4c0a-834a-b2bc654b0827
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSET KIT
• Version Model Number: HESEK
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809892339845 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

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

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

[08809892339845]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [ESSET KIT]

• 08809892339883: OESEK
• 08809892339845: HESEK