FDA.reportPublic FDA data

Sterile Silver Alginate Wound Dressing

Primary DI
16934889085104
Brand
Sterile Silver Alginate Wound Dressing
Company
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Model
4.25in×4.25in (11cm×11cm)
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
16934889085104PackageGS15In Commercial Distribution
06934889085008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693488908510416934889085104
06934889085008069348890850086934889085008

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
421362069
Device count
1
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
true
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
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
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
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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Primary DI, Brand, Company table
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10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
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