Omni-stat Granules FG07730591

GUDID 15060206630588

Hemostatic Granules. For minor external bleeding from wounds and procedures the device is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. For moderate to severe external bleeding wounds the device is indicated for temporary external treatment for controlling moderate to severe bleeding.

MEDTRADE PRODUCTS LIMITED

Chitosan haemostatic agent

• Primary Device ID: 15060206630588
• NIH Device Record Key: 42079cfd-e596-41ce-a16c-9d5e5ba44684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni-stat Granules
• Version Model Number: FG07730591
• Catalog Number: FG07730591
• Company DUNS: 238476068
• Company Name: MEDTRADE PRODUCTS LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com

Device Dimensions

• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060206630588 [Primary]
GS1	35060206630582 [Package]; Package: Shelf Carton [10 Units]; In Commercial Distribution
GS1	75060206630580 [Package]; Contains: 35060206630582; Package: Shipper Case [10 Units]; In Commercial Distribution

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: 2019-12-11
• Device Publish Date: 2019-12-03

Devices Manufactured by MEDTRADE PRODUCTS LIMITED

• 75060206631570 - Celox Rapid: 2024-09-09 Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque
• 35060206631589 - Celox Rapid: 2024-09-09 Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque
• 75060206631600 - Celox Rapid (MARCH): 2024-09-09 Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque
• 15060206631653 - Foxseal Vented: 2024-09-09 Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (Japanese / English pack)
• 15060206631318 - CELOX RAPID Z-Fold Gauze: 2022-09-08 Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules with Chito-R technology. Dressing is indicated f
• 75060206631396 - CELOX Gauze Z-Fold: 2022-09-08 Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dressing is indicated for temporary externa
• 75060206631365 - FOXSEAL: 2022-04-08 Occlusive dressings for open chest wounds. For use by emergency trained responders (CE& US Swedish/ Norwegian/English Pack)
• 15060206631288 - FOXSEAL Vented: 2022-02-21 Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (French/German/ English pack)