FDA.reportPublic FDA data

Sterile Silver Alginate Wound Dressing

Primary DI
06934889086098
Brand
Sterile Silver Alginate Wound Dressing
Company
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Model
4in×5in (10cm×12.5cm)
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
16934889086194PackageGS110In Commercial Distribution
26934889086290PackageGS140In Commercial Distribution
06934889086098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693488908619416934889086194
2693488908629026934889086290
06934889086098069348890860986934889086098

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
06934889085022Sterile Silver Alginate Wound Dressing3in×4.8in (7.5cm×12cm)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
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

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