FDA.reportPublic FDA data

Master

Primary DI
06975374671214
Brand
Master
Company
Dongguan Maisite Medical Instruments Co., Ltd.
Model
gel
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
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
06975374671214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975374671214069753746712146975374671214

GMDN Terms#

Term, Definition table
TermDefinition
Emphysematous lung sealantA sterile fluid material intended to be introduced into the alveoli and bronchioles of targeted emphysematous lung subsegments where it gels to permanently seal the spaces and create a localized, post-obstructive atelectasis (airless/collapsed lung) as a therapeutic measure for a patient with advanced emphysema. It is typically administered by a pulmonologist or a thoracic surgeon as a liquid foam through a bronchoscopic catheter. 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
06975374671313Masterstainless steel2023-05-12
06975374671412MasterPolyester Fiber2023-05-12
06975374671610Masternonwovens2023-05-12
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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10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
10885632506024HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
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
00324357200457Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357200488Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357200884Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357404145Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357410078Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21