EcoGel 200 Clear

GUDID 00628055650751

EcoGel 200 Clear High Viscosity

Eco-Med Pharmaceutical Inc

Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• 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