FDA.reportPublic FDA data

Master

Primary DI
06975374671610
Brand
Master
Company
Dongguan Maisite Medical Instruments Co., Ltd.
Model
nonwovens
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975374671610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975374671610069753746716106975374671610

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent stomal dressingAn absorbent protective covering/pad intended to be placed over a urinary or enteric stoma to protect it from harmful external influences, absorb and prevent the spread of sweat and stomal fluid/waste/leaks, and to protect the surrounding skin from irritation. It typically has a central hole and is typically attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin, or attached around the connection between an ostomy base plate and an ostomy bag. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
711262474
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975374671511MasterPET2023-05-12
06975374678015MasterMetal2023-05-12
06975374677018MasterABS2023-05-12
06975374671115MasterSpinning type2023-05-12
06975374671214Mastergel2023-05-12
06975374671313Masterstainless steel2023-05-12
06975374671412MasterPolyester Fiber2023-05-12
06975374679012MasterFoam2023-05-12
06975374675014MasterCotton2023-05-11
06975374676011MasterOxford Cloth Kit2023-05-11
06975374674017MasterPP2023-05-10
06975374671016MasterPolyester Fiber2023-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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