HCT

GUDID 00852937003087

INNOVATE MEDICAL, LLC

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 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 Skin topical coupling gel

• Primary Device ID: 00852937003087
• NIH Device Record Key: 83424a7c-b15b-4152-87cb-f7724e0175d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCT
• Version Model Number: HCT9849-1
• Company DUNS: 050339980
• Company Name: INNOVATE MEDICAL, LLC
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852937003087 [Primary]
GS1	10852937003084 [Package]; Package: Case [50 Units]; In Commercial Distribution

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

On-Brand Devices [HCT]

• 00852937003087: HCT9849-1
• 00852937003070: HCTBBD-100