FDA.reportPublic FDA data

MemGard

Primary DI
06974843741571
Brand
MemGard
Company
Dalian Orientech Co.,Ltd
Model
MEMGARD WIC Plus 7.5×7.5
Published
2026-03-10
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
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
06974843741571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974843741571069748437415716974843741571

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544719180
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974843740574MemGardMEMGARD Non-Border 3×82026-03-10
06974843740581MemGardMEMGARD Non-Border 3×102026-03-10
06974843740598MemGardMEMGARD Non-Border 3×122026-03-10
06974843740604MemGardMEMGARD Non-Border 3×142026-03-10
06974843740741MemGardMEMGARD Non-Border 3×182026-03-10
06974843740758MemGardMEMGARD Non-Border 4x102026-03-10
06974843740765MemGardMEMGARD Non-Border 5x142026-03-10
06974843740772MemGardMEMGARD Non-Border Φ6.52026-03-10
06974843740789MemGardMEMGARD Non-Border Φ72026-03-10
06974843740796MemGardMEMGARD Non-Border 5×52026-03-10
06974843740802MemGardMEMGARD Non-Border 6×82026-03-10
06974843740819MemGardMEMGARD Non-Border 7.5×7.52026-03-10
06974843740826MemGardMEMGARD Non-Border 10×102026-03-10
06974843740833MemGardMEMGARD Non-Border 10×202026-03-10
06974843740840MemGardMEMGARD Non-Border 10×302026-03-10
06974843740857MemGardMEMGARD Non-Border 10×612026-03-10
06974843740864MemGardMEMGARD Non-Border 12.5×12.52026-03-10
06974843740871MemGardMEMGARD Non-Border 12.5×17.52026-03-10
06974843740888MemGardMEMGARD Non-Border 15×152026-03-10
06974843740895MemGardMEMGARD Non-Border 17×192026-03-10

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Primary DI, Brand, Company table
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
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