FDA.reportPublic FDA data

MemGard

Primary DI
06974843740581
Brand
MemGard
Company
Dalian Orientech Co.,Ltd
Model
MEMGARD Non-Border 3×10
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
06974843740581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974843740581069748437405816974843740581

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. 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
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
06974843740901MemGardMEMGARD Non-Border 20×202026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
10840330701591ProCureTwin Med, LLCNAD2026-04-28
10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
10840330704899ProCureTwin Med, LLCNAD2026-04-22
10840330705032ProCureTwin Med, LLCNAD2026-04-22
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21
10192253038828KendallCardinal Health 200, LLCNAD2025-11-21
10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169344MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169351MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169368MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169375MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344162505MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162529MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162536MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10197344162543MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-17
10080196735662MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-10-15