ET RIGID RETRACTION CAP

GUDID 00810019240263

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810019240263
• NIH Device Record Key: 8f2d5823-06da-46c4-aa3d-825515232647
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET RIGID RETRACTION CAP
• Version Model Number: ETRRC461
• 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: false
• 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	00810019240263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161689

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [ET RIGID RETRACTION CAP]

• 00810019240348: ETRRC760
• 00810019240331: ETRRC670
• 00810019240324: ETRRC660
• 00810019240317: ETRRC640
• 00810019240300: ETRRC570
• 00810019240294: ETRRC560
• 00810019240287: ETRRC540
• 00810019240270: ETRRC471
• 00810019240263: ETRRC461
• 00810019240256: ETRRC441
• 00810019240249: ETRRC470
• 00810019240232: ETRRC460
• 00810019240225: ETRRC440