FDA.reportPublic FDA data

Skinsafe Plus Ag

Primary DI
05060786987556
Brand
Skinsafe Plus Ag
Company
SPECIALITY FIBRES AND MATERIALS LIMITED
Model
Skinsafe Plus Ag 120 10x12.5
Catalog number
FT650667
Device description
Skinsafe Plus Ag 120 10x12.5
Published
2023-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K183208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183208000Suprasorb A + Ag “R”Speciality Fibres and Materials, Ltd.2019-08-15FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060786987556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060786987556050607869875565060786987556

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. 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
219041423
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059884010938DURAFIBER Ag PRO 10x12cmFV001021660276822026-02-09
05059884010945DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
05059884010952DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
05059884010969DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
05059884010976DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05059884010921DURAFIBER Ag PRO 10x10cmFV001020660276782026-02-09
15059884010935DURAFIBER Ag PRO 10x12cmFV001021660276822026-02-09
15059884010942DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
15059884010959DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
15059884010966DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
15059884010973DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05060786987549Skinsafe Plus AgSkinsafe Plus Ag 120 5x5FT6506662023-11-14
05060786981462Suprasorb ASuprasorb A L130 10x10cm204412024-05-22
05060786981479Suprasorb ASuprasorb A L130 10x12.5cm309902024-05-22
05060786981486Suprasorb ASuprasorb A L130 10x20cm204422024-05-22
05060786981493Suprasorb ASuprasorb A L130 2x30cm204452024-05-22
05060786981509Suprasorb ASuprasorb A L130 5x5cm204402024-05-22
05059884010365Skinsafe PlusSkinsafe Plus 120 5x5FP6506642023-11-14
05059884010372Skinsafe PlusSkinsafe Plus 120 10x12.5FP6506652023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29