FDA.reportPublic FDA data

Hydrocolloid Dressing

Primary DI
06970206823847
Brand
Hydrocolloid Dressing
Company
Jiangsu NewValue Medical Products Co.,Ltd.
Model
Thin
Device description
1pc/bag, 10bags/box, 100boxes/case
Published
2023-06-13
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970206823844PackageGS110In Commercial Distribution
26970206823841PackageGS1100In Commercial Distribution
06970206823847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697020682384416970206823844
2697020682384126970206823841
06970206823847069702068238476970206823847

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Regulatory Flags#

DUNS number
544401775
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970206823830Hydrocolloid DressingStandard2023-06-13
06970206825148Disposable Surgical Face MaskEL-L032023-06-13
06970206825162Disposable Surgical Face MaskEL-L032023-06-13
06970206823816ACNE PIMPLE PATCHESC71001-07892023-06-09
06970206822550 Disposable Surgical Face MaskEL-L032021-04-23
16970206823837Hydrocolloid DressingStandard2023-06-13
16970206823844Hydrocolloid DressingThin2023-06-13
06970206825155Disposable Surgical Face MaskEL-L032023-06-13
06970206825179Disposable Surgical Face MaskEL-L032023-06-13

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