Sterile Silver Alginate Wound Dressing

GUDID 16934889085029

QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID16934889085029
NIH Device Record Keyf76b9bae-c9a5-4e57-beed-a3fa04b09c35
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Silver Alginate Wound Dressing
Version Model Number3in×4.8in (7.5cm×12cm)
Company DUNS421362069
Company NameQINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106934889085022 [Primary]
GS116934889085029 [Package]
Contains: 06934889085022
Package: [5 Units]
In Commercial Distribution
GS116934889085128 [Package]
Contains: 06934889085022
Package: [10 Units]
In Commercial Distribution
GS126934889085026 [Package]
Package: [40 Units]
In Commercial Distribution
GS126934889085125 [Package]
Contains: 16934889085128
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-06
Device Publish Date2025-04-28

On-Brand Devices [Sterile Silver Alginate Wound Dressing]

169348890861944in×5in (10cm×12.5cm)
169348890850980.8in×17.6in (2cm×44cm)
169348890850293in×4.8in (7.5cm×12cm)
169348890851044.25in×4.25in (11cm×11cm)

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