FDA.reportPublic FDA data

CELOX- A CMS

Primary DI
35060206630865
Brand
CELOX- A CMS
Company
MEDTRADE PRODUCTS LIMITED
Model
FG05832101
Catalog number
30-235
Device description
Hemostatic Granules in an Applicator - Indicated for Temporary traumatic wound treatment to control moderate to severe bleeding. For temporary external use only
Published
2021-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35060206630865PackageGS110In Commercial Distribution
75060206630863PackageGS15In Commercial Distribution
15060206630861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506020663086535060206630865
7506020663086375060206630863
1506020663086115060206630861

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professionalA 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
Weight6Gram

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
238476068
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
15060206631608Celox Rapid (MARCH)FG05839331FG058393312024-08-31

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