Endogel EG-S

GUDID 00859611006006

Dental Root Canal Lubricating and Cleanser gel, 12 tubes per pack

JORDCO INC

Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution Root canal cleaning solution

• Primary Device ID: 00859611006006
• NIH Device Record Key: cc73d727-5956-46e1-9992-f4df5dec8ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endogel
• Version Model Number: EG-s
• Catalog Number: EG-S
• Company DUNS: 803063981
• Company Name: JORDCO 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859611006006 [Primary]
GS1	00859611006013 [Package]; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992484

FDA Product Code

• KJJ: Cleanser, Root Canal

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: 2020-08-17
• Device Publish Date: 2020-08-08

On-Brand Devices [Endogel]

• 00859611006006: Dental Root Canal Lubricating and Cleanser gel, 12 tubes per pack
• 00859611006716: Endodontic Lubricating Gel: Bulk Pack of 288 tubes