CELOX Vascular FG08834081

GUDID 35060206630643

Hemostatic Pad: The device is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16 French. The hemostatic pad is for temporary external use only.

MEDTRADE PRODUCTS LIMITED

Chitosan haemostatic agent
Primary Device ID35060206630643
NIH Device Record Key99d9ece5-2afb-4565-9d1c-6ee3e81b3592
Commercial Distribution StatusIn Commercial Distribution
Brand NameCELOX Vascular
Version Model NumberFG08834081
Catalog NumberFG08834081
Company DUNS238476068
Company NameMEDTRADE PRODUCTS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk
Phone+4401270500019
Emailinfo@medtrade.co.uk

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS115060206630649 [Primary]
GS135060206630643 [Package]
Contains: 15060206630649
Package: Carton [10 Units]
In Commercial Distribution
GS175060206630641 [Package]
Package: Shipper Case [10 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

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 Rapid2024-09-09 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 Gauze2022-09-08 Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules with Chito-R technology. Dressing is indicated f
75060206631396 - CELOX Gauze Z-Fold2022-09-08 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 Vented2022-02-21 Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (French/German/ English pack)

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