EcoGel 200 Clear

GUDID 00628055650751

EcoGel 200 Clear High Viscosity

Eco-Med Pharmaceutical Inc

Coupling gel, non-sterile

• Primary Device ID: 00628055650751
• NIH Device Record Key: 073533bd-6f8f-476b-82e1-61036fccd168
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoGel 200 Clear
• Version Model Number: 40JBC-HV-24
• Company DUNS: 249183435
• Company Name: Eco-Med Pharmaceutical 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055650737 [Primary]
GS1	00628055650744 [Package]; Contains: 00628055650737; Package: Case [12 Units]; In Commercial Distribution
GS1	00628055650751 [Package]; Contains: 00628055650737; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955246

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-12-28
• Device Publish Date: 2020-12-18

Devices Manufactured by Eco-Med Pharmaceutical Inc

• 00628055650751 - EcoGel 200 Clear: 2020-12-28EcoGel 200 Clear High Viscosity
• 00628055650751 - EcoGel 200 Clear: 2020-12-28 EcoGel 200 Clear High Viscosity
• 00628055650492 - EcoGel 200: 2020-01-23 Blue 20g Packet
• 00628055650553 - EcoGel 200: 2020-01-23 High-Viscosity Clear 20g Packet
• 00628055650584 - EcoGel 200: 2020-01-23 High-Viscosity Blue 20g Packet
• 00628055650683 - EcoGel 200: 2020-01-23 Clear 20g Packet
• 00628055650706 - EcoGel 200: 2020-01-23 High-Viscosity Blue 250ml Bottle
• 00628055650973 - EcoGel 200: 2020-01-23 High-Viscosity Clear
• 00628055650713 - EcoGel 200: 2020-01-23 High-Viscosity Blue 5L Cube