FDA.reportPublic FDA data

Huibo Medical

Primary DI
06936943411471
Brand
Huibo Medical
Company
Henan Huibo Medical Co.,Ltd.
Model
10*10cm
Device description
Applied to acute and chronic wounds with much exudates on superficial dermis and above. It can absorb the exudates and promote wound healing.
Published
2020-01-21
Public version status
Update
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
06936943411471PrimaryGS10
06936943411600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936943411471069369434114716936943411471
06936943411600069369434116006936943411600

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, sterileA sterile wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560455084
Device count
10
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
06936943403087Huibo Medical4*30cm2020-02-26
06936943403094Huibo Medical12*15cm2020-02-26
06936943404039Huibo Medical25g2020-02-28
06936943404022Huibo Medical15g2020-01-21
06936943403100Huibo Medical6cm*8cm2020-01-20
06936943411136Huibo Medical10*10cm2020-01-21
06936943411150Huibo Medical10cm*10cm2020-01-21
06936943411488Huibo Medical10*10cm2020-01-21
06936943400598Huibo Medical10*10cm, border2020-01-21
06936943412416Huibo Medical10*10cm, borderless2020-01-21
06936943411839Huibo MedicalI-AD-S, open toe, beige2020-02-28
06936943411846Huibo MedicalI-AD-M, Beige, Open toe2020-02-28
06936943411853Huibo MedicalI-AD-L, Beige, Open toe2020-02-26
06936943472175Huibo MedicalII-AD-M2020-01-21
06936943403070Huibo Medical4*30cm2020-02-26
06936943403063Huibo Medical12*15cm2020-02-26
06936943411457Huibo Medical25*10mm2020-02-26

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Primary DI, Brand, Company table
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