FDA.reportPublic FDA data

GUANGYI

Primary DI
06974692681127
Brand
GUANGYI
Company
Jiangsu Guangyi Medical Dressing Co.,LTD.
Model
Non-woven 10cm×25cm
Published
2025-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974692681124PackageGS130In Commercial Distribution
06974692681127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697469268112416974692681124
06974692681127069746926811276974692681127

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
526901056
Device count
1
Premarket exempt
true
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
06974692681349GUANGYINON-WOVEN FABRICS WITH ABSORBENT PAD10cm×20cm2026-04-13
06974692681356GUANGYINON-WOVEN FABRICS WITH ABSORBENT PAD10cm×30cm2026-04-13
06974692681073GUANGYIPU type 10cm×12cm2025-09-08
06974692681110GUANGYINon-woven type 10cm×10cm2025-11-05
16974692681070GUANGYIPU type 10cm×12cm2025-09-08
06974692680007GUANGYIPU, 15cm*10m2022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
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09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22