Healing Cap

GUDID 07290112442444

Healing Cap standard

ETGAR - MEDICAL INSTRUMENTS LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07290112442444
• NIH Device Record Key: 5e5e84b2-9f31-406d-8c77-93e2e4f8297e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Cap
• Version Model Number: EI-5005
• 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	07290112442444 [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

[07290112442444]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-02-27

On-Brand Devices [Healing Cap]

• 07290112442567: Healing Cap Wide
• 07290112442550: Healing Cap Wide
• 07290112442543: Healing Cap Wide
• 07290112442536: Healing Cap Wide
• 07290112442529: Healing Cap Narrow
• 07290112442512: Healing Cap Narrow
• 07290112442505: Healing Cap Narrow
• 07290112442499: Healing Cap Narrow
• 07290112442482: Healing Cap Narrow
• 07290112442475: Healing Cap Narrow
• 07290112442468: Healing Cap standard
• 07290112442451: Healing Cap standard
• 07290112442444: Healing Cap standard
• 07290112442437: Healing Cap standard
• 07290112442420: Healing Cap standard
• 07290112442413: Healing Cap standard