FDA.reportPublic FDA data

SureStop

Primary DI
16940610100503
Brand
SureStop
Company
Huizhou Foryou Medical Devices Co., Ltd.
Model
19x19mm
Device description
SureStop Topical Hemostatic Dressing
Published
2020-05-26
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
26940610100500PackageGS1200In Commercial Distribution
16940610100503PrimaryGS10
06940610100506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2694061010050026940610100500
1694061010050316940610100503
06940610100506069406101005066940610100506

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+867525302185hyylqa@foryougroup.com

Regulatory Flags#

DUNS number
529904325
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
86940610104432LUOFUCON100×100 mm2026-03-25
86940610104449LUOFUCON100×100 mm2026-03-25
86940610104456LUOFUCON100×100 mm2026-03-25
86940610104463LUOFUCON100ml2026-03-25
06940610104726Vliwasorb75×75 (50×50)mm1418202025-11-18
06940610104733Vliwasorb125×125 (100×100)mm1418212025-11-18
06940610104740Vliwasorb100×200 (75×170)mm1418222025-11-18
06940610104757Vliwasorb150×250 (120×220)mm1418232025-11-18
06940610104764Vliwasorb200×200(170×170)mm1418242025-11-18
06940610104771Vliwasorb200×300(170×270)mm1418252025-11-18
06940610127756Vliwasorb130×130(75×75)mm1595592025-11-18
06940610127817Vliwasorb250×150 (190×90)mm1595612025-11-18
06940610104788Vliwasorb75×75 (50×50)mm1418202025-11-18
06940610104795Vliwasorb125×125 (100×100)mm1418212025-11-18
06940610104801Vliwasorb100×200 (75×170)mm1418222025-11-18
06940610104818Vliwasorb150×250 (120×220)mm1418232025-11-18
06940610104825Vliwasorb200×200(170×170)mm1418242025-11-18
06940610104832Vliwasorb200×300(170×270)mm1418252025-11-18
06940610127763Vliwasorb130×130(75×75)mm1595592025-11-18
06940610127824Vliwasorb250×150 (190×90)mm1595612025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
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
10192253047868XeroformCardinal Health 200, LLCFRO2025-09-22