FDA.reportPublic FDA data

BGEcare Sterile Non-woven Island Dressing

Primary DI
06959385794308
Brand
BGEcare Sterile Non-woven Island Dressing
Company
Zhende Medical Co., Ltd.
Model
ID0404015012S
Device description
BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/carton box
Published
2021-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
06959385794315PackageGS150In Commercial Distribution
06959385794322PackageGS112In Commercial Distribution
06959385794308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959385794315069593857943156959385794315
06959385794322069593857943226959385794322
06959385794308069593857943086959385794308

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
654591569
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959385787003ZDLYRC1200012023-06-22
06942273317574ZDNUMT0062024-01-22
06942273317598ZDNUMT0052024-01-22
06942273317611ZDNUMT0082024-01-22
06942273317635ZDNUMT0072024-01-22
06942273317659ZDNUMT0022024-01-22
06942273317673ZDNUMT0012024-01-22
06942273317697ZDNUMT0042024-01-22
06942273317710ZDNUMT0032024-01-22
06942273317734ZDNUMT0092024-01-22
06942273317758ZDNUMT0112024-01-22
06942273317772ZDNUMT0102024-01-22
06942273317796ZDNUMT0132024-01-22
06942273317819ZDNUMT0122024-01-22
06942273317833ZDNUMT0152024-01-22
06942273317857ZDNUMT0142024-01-22
06942273317871ZDNUMT0162024-01-22
06942273317895ZDNUMT016S2024-01-22
06942273317918ZDNUMT0172024-01-22
06942273317932ZDNUMT017S2024-01-22

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Primary DI, Brand, Company table
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00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
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09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22