FDA.reportPublic FDA data

CELOX Rapid Z-Fold Gauze - MARCH CMS

Primary DI
15060206630618
Brand
CELOX Rapid Z-Fold Gauze - MARCH CMS
Company
MEDTRADE PRODUCTS LIMITED
Model
FG05839071
Catalog number
30-215
Device description
Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to control moderate to severe bleeding. For use by trained emergency responders.Chito-R Technology
Published
2021-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07500206630610PackageGS1100In Commercial Distribution
15060206630618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500206630610075002066306107500206630610
1506020663061815060206630618

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
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
15060206631318CELOX RAPID Z-Fold GauzeFG08839241FG088392412022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22