FDA.reportPublic FDA data

SureStop

Primary DI
26940610100500
Brand
SureStop
Company
Huizhou Foryou Medical Devices Co., Ltd.
Model
19x19mm
Device description
SureStop Topical Hemostatic Dressing
Published
2020-05-26
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
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-bioabsorbableA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
529904325
Device count
20
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
06940610127725Vliwasorb105×105(50×50)mm1595582026-08-14
06940610127787Vliwasorb180×180(125×125)mm1595602026-08-14
06940610127848Vliwasorb250×200(190×140)mm1595622026-08-14
06940610127879Vliwasorb185×180(125×120)mm1595682026-08-14
06940610127909Vliwasorb230×230(170×165)mm1595692026-08-14
06940610127930Vliwasorb220×220(160×155)mm1595702026-08-14
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

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00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
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10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
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00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26