FDA.reportPublic FDA data

Celox Rapid (MARCH)

Primary DI
15060206631608
Brand
Celox Rapid (MARCH)
Company
MEDTRADE PRODUCTS LIMITED
Model
FG05839331
Catalog number
FG05839331
Device description
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. The device may be left in place for up to 72 hours.
Published
2024-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
75060206631600PackageGS1100In Commercial Distribution
15060206631608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7506020663160075060206631600
1506020663160815060206631608

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professional, non-bioabsorbableA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5Feet
Width3Inch

Contacts#

Phone, Email table
PhoneEmail
+4401270500019info@medtrade.co.uk

Regulatory Flags#

DUNS number
238476068
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060206630014CELOX AFG08832071FG088320712021-01-29
15060206630038Celox GauzeFG08838011FG088380112021-07-31
15060206630106CELOX GranulesFG08830551FG088305512020-09-23
15060206630151CELOX GauzeFG08838021FG088380212021-01-29
15060206630168CELOX EMSFG08834291FG088342912020-09-23
15060206630175CELOX EMSFG08834281FG088342812020-09-23
15060206630595Omni-stat Hemostatic GauzeFG07734331FG077343312020-01-17
15060206630601CELOX Rapid FG08839061FG088390612021-05-31
15060206630618CELOX Rapid Z-Fold Gauze - MARCH CMSFG0583907130-2152021-01-29
15060206630625OMNI-STAT Hemostatic GauzeFG04534191FG045341912020-05-28
15060206630649CELOX VascularFG08834081FG088340812020-09-23
15060206630656CELOX GranulesFG08830441FG088304412020-09-23
15060206630762CELOX RAPID RibbonFG08839041FG088390412021-05-31
15060206630847CELOX Rapid Ribbon - CMSFG0583914130-2232021-07-31
15060206630854CELOX Rapid Z-fold Gauze - B-ConFG0583915130-2122021-03-31
15060206630861CELOX- A CMSFG0583210130-2352021-07-31
15060206631394CELOX Gauze Z-FoldFG08838181FG088381812022-08-31
15060206631578Celox Rapid FG08839251FG088392512024-08-31
15060206631585Celox RapidFG08839291FG088392912024-08-31
15060206631318CELOX RAPID Z-Fold GauzeFG08839241FG088392412022-08-31

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