FDA.reportPublic FDA data

MEDLOT

Primary DI
06974795059106
Brand
MEDLOT
Company
Henan Maidingkang Medical Technology Co., Ltd.
Model
44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+20
Published
2026-05-06
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
06974795059106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974795059106069747950591066974795059106

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
724981491
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
06974795059540MEDLOT44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+202026-05-06
06974795053920MEDLOT10*10cm2026-03-13
06974795054392MEDLOT5cm*4.88m2026-01-06
06974795059120MEDLOT10*10cm2025-10-09
06974795053142MEDLOT15*15cm2025-09-29
06974795055474MEDLOT15*15cm2025-09-29
06974795056341MEDLOT5cm*4.88m2025-08-22
06974795057256MEDLOT5cm*3.66m2025-08-22
06974795058314MEDLOT5cm*3.66m2025-08-22
06974795051940MEDLOT4cm*2m2025-08-13
06974795055580MEDLOT4cm*2m2025-08-13
06974795059861MEDLOT4cm*4m2025-08-13
06974795057119MEDLOT10*10cm2025-08-04
06974795058864MEDLOT10*10cm2025-08-04
06974795056150MEDLOT15*15cm2025-08-01
06974795053371MEDLOT10*18cm2025-07-29
06974795057508MEDLOT4*15cm2025-07-29
06974795056242MEDLOT4*15cm2025-06-12
06974795052107MEDLOT10*18cm2025-06-11
06974795053258MEDLOT10*18cm2025-06-11

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