FDA.reportPublic FDA data

SPECIALTY

Primary DI
06972077026600
Brand
SPECIALTY
Company
XIAMEN TAFT MEDICAL CO.,LTD.
Model
SPF-ACT3060NST-M
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INWTable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INWTable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972077026600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972077026600069720770266006972077026600

GMDN Terms#

Term, Definition table
TermDefinition
Rickettsia rickettsii immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the rickettsial bacteria Rickettsia rickettsii in a clinical specimen.

Regulatory Flags#

DUNS number
530563253
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972077026532PROHEALPMOVBT-OAK-MP2026-05-15
06972077026563PROHEALPMOVBT-GRY-MP2026-05-15
06972077026570PROHEALPMOVBT-MGY-MP2026-05-15
06972077026587EvermedWARMRESTSETBLK2026-05-15
06972077026594SPECIALTYSPF-ACT3060NST-C2026-05-15
06972077026617SPECIALTYSPF-ACT3060NST-MC2026-05-15
06972077026624SPECIALTYSPF-ACT3060NST-W2026-05-15
06972077026631CostcareT110-M2026-05-15
06972077026648CostcareT-1202026-05-15
06972077026655JOYT120-J2026-05-15
06972077026662JOYTPT120-J2026-05-15
06972077026679EvermedW20CHAIRBACKBLK2026-05-15
06972077026686EvermedW8INWHEELBLK2026-05-15
06972077026693EvermedWFNTFORKSMET2026-05-15
06972077026709EvermedWSLIDEBARHNDLRED2026-05-15
06972077026716EvermedWSSLGWHLATTKITMET2026-05-15
06972077026723EvermedWSSLHFTRESTWWHLBLK2026-05-15
06972077026730EvermedWSSRHFTRESTWWHLBLK2026-05-15
06972077026891ADCOB103ALPBK2026-05-15
06972077026907ADCOA1803BK2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077026532PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026563PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026570PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026594SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026617SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026624SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026631CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026648CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026655JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026662JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
00815235022617UMF MedicalUNITED METAL FABRICATORS, INC.INW2026-05-14
06972077026433ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026440ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026549ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026556PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026259EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026280EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026297EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026303EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026761EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026778EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026174CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026181CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026211CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026310ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
05715393022809R82R82 A/SINW2026-01-20
05715393022816R82R82 A/SINW2026-01-20
05715393022823R82R82 A/SINW2026-01-20
05715393022830R82R82 A/SINW2026-01-20
10705037046430STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.INW2025-12-16