Titanium Sleeve for Multi-Unit

GUDID 07290112444325

Titanium Short Sleeve for Multi-Unit Screw included

ETGAR - MEDICAL INSTRUMENTS LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290112444325
• NIH Device Record Key: bbf8a6f2-d923-47f1-a0e8-4481649e8fa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanium Sleeve for Multi-Unit
• Version Model Number: EI-4498
• Company DUNS: 514570324
• Company Name: ETGAR - MEDICAL INSTRUMENTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	07290112444325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161743

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290112444325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-03-01

On-Brand Devices [Titanium Sleeve for Multi-Unit]

• 07290112444325: Titanium Short Sleeve for Multi-Unit Screw included
• 07290112444318: Titanium Sleeve for Multi-Unit Screw included