FDA.reportPublic FDA data

ComfortFoam/Ag Border

Primary DI
00714196391087
Brand
ComfortFoam/Ag Border
Company
Sion Brands LLC
Model
48220
Published
2021-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170077000LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.2017-03-30FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714196391087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196391087007141963910877141963910870714196391087

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118753405
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196322227AquaDerm00322E2020-09-01
01714196634404HydraLock SA with Border634402026-07-16
01714196635500HydraLock SA with Border635502026-07-16
01714196637702HydraLock SA with Border637702026-07-16
00714196003317DermaCol 100 Gel 1oz Tube0033112026-06-01
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz Tube111052026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz Tube111072026-06-01
01714196112452DermaRite Medical Wound Gel- Amorphous Hydrogel112452026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4222042026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4333042026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz Tube20301US2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz Tube20501US2026-06-01
00714196112453DermaSyn112452020-09-01
00714196930712Bordered Foam Healogics by DermaRite930712020-09-01
00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
01714196422629ComfortGauze Border422622025-01-08
01714196422636ComfortGauze Border422632025-01-08
07141964645074AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
71419624712486DermaSyn002472024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08