HemCon® Dental Dressing PRO, 1in x 3in 1052

GUDID 20870053001118

The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

TRICOL BIOMEDICAL, INC.

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived

• Primary Device ID: 20870053001118
• NIH Device Record Key: f740a971-7324-4004-8168-cacb44acca35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemCon® Dental Dressing PRO, 1in x 3in
• Version Model Number: 1
• Catalog Number: 1052
• Company DUNS: 080240553
• Company Name: TRICOL BIOMEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 11 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00870053001114 [Primary]
GS1	20870053001118 [Package]; Contains: 00870053001114; Package: Box [12 Units]; In Commercial Distribution
GS1	50870053001119 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060363

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2021-07-19
• Device Publish Date: 2021-07-09

Devices Manufactured by TRICOL BIOMEDICAL, INC.

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• 20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in: 2021-07-19The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
• 20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in: 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
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