FDA.reportPublic FDA data

Sterile Silver Alginate Wound Dressing

Primary DI
06934889085022
Brand
Sterile Silver Alginate Wound Dressing
Company
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Model
3in×4.8in (7.5cm×12cm)
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K220673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220673000Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.2023-03-16FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16934889085029PackageGS15In Commercial Distribution
16934889085128PackageGS110In Commercial Distribution
26934889085026PackageGS140In Commercial Distribution
26934889085125PackageGS140In Commercial Distribution
06934889085022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693488908502916934889085029
1693488908512816934889085128
2693488908502626934889085026
2693488908512526934889085125
06934889085022069348890850226934889085022

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.

Regulatory Flags#

DUNS number
421362069
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934889080010CMC Fiber Dressing 2in*2in (5cm*5cm)2025-04-28
06934889080027CMC Fiber Dressing 4in*4in (10cm*10cm)2025-04-28
06934889080034CMC Fiber Dressing 6in*6in(15cm*15cm)2025-04-28
06934889085008Sterile Silver Alginate Wound Dressing4.25in×4.25in (11cm×11cm)2025-04-28
06934889085046Alginate Wound Dressing4in×8in (10cm*20cm)2025-04-28
06934889085053Alginate Wound Dressing0.8in×1.8in (2cm×4.5cm)2025-04-28
06934889085077Alginate Wound Dressing4.3in×4.3in (10.8cm×10.8cm)2025-04-28
06934889085091Sterile Silver Alginate Wound Dressing0.8in×17.6in (2cm×44cm)2025-04-28
06934889085114Alginate Wound Dressing4.25in×4.25in (10.8cm×10.8cm)2025-04-28
06934889085145Alginate Wound Dressing4in×8in (10.2cm×20.4cm)2025-04-28
06934889085312 Alginate Wound Dressing0.3g*4.5cm2025-04-28
06934889086098Sterile Silver Alginate Wound Dressing4in×5in (10cm×12.5cm)2025-04-28
16934889080116CMC Fiber Dressing 2in*2in (5cm*5cm)2025-04-28
16934889080123CMC Fiber Dressing 4in*4in (10cm*10cm)2025-04-28
16934889080130CMC Fiber Dressing 6in*6in(15cm*15cm)2025-04-28
16934889085104Sterile Silver Alginate Wound Dressing4.25in×4.25in (11cm×11cm)2025-04-28
16934889085029Sterile Silver Alginate Wound Dressing3in×4.8in (7.5cm×12cm)2025-04-28
16934889085142Alginate Wound Dressing4in×8in (10cm*20cm)2025-04-28
16934889085357Alginate Wound Dressing0.8in×1.8in (2cm×4.5cm)2025-04-28
16934889085272Alginate Wound Dressing4.3in×4.3in (10.8cm×10.8cm)2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
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
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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