HemCon GuardaCare® PRO, 2in x 2in, 8ply 1012

GUDID 00870053001350

HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent

• Primary Device ID: 00870053001350
• NIH Device Record Key: 6673271b-92c8-4fdb-a998-e5ad9ae4db63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemCon GuardaCare® PRO, 2in x 2in, 8ply
• Version Model Number: 1
• Catalog Number: 1012
• 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
• 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
• 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	00870053001350 [Primary]
GS1	20870053001354 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	50870053001355 [Package]; Contains: 20870053001354; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092357

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2020-12-18
• Device Publish Date: 2020-12-10

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