FDA.reportPublic FDA data

Rigid Uterine Aspiration Curette

Primary DI
06974500612763
Brand
Rigid Uterine Aspiration Curette
Company
GCMEDICA ENTERPRISE LTD.(WUXI)
Model
GC7049A12AU01
Device description
Rigid Curette, straight, 12 mm
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHKCurette, Suction, Endometrial (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHKCurette, Suction, Endometrial (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974500612760PackageGS110In Commercial Distribution
26974500612767PackageGS125In Commercial Distribution
06974500612763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697450061276016974500612760
2697450061276726974500612767
06974500612763069745006127636974500612763

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, suctionA sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.

Regulatory Flags#

DUNS number
560122957
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974500612718Rigid Uterine Aspiration CuretteGC7049A07AU012026-05-18
06974500612725Rigid Uterine Aspiration CuretteGC7049A08AU012026-05-18
06974500612732Rigid Uterine Aspiration CuretteGC7049A09AU012026-05-18
06974500612749Rigid Uterine Aspiration CuretteGC7049A10AU012026-05-18
06974500612756Rigid Uterine Aspiration CuretteGC7049A11AU012026-05-18
06974500612770Rigid Uterine Aspiration CuretteGC7049A14AU012026-05-18
06974500612787Rigid Uterine Aspiration CuretteGC7049A16AU012026-05-18
06974500612794Rigid Uterine Aspiration CuretteGC7049D14AU012026-05-18
06974500612824Rigid Uterine Aspiration CuretteGC7049B07BU012026-05-18
06974500612831Rigid Uterine Aspiration CuretteGC7049B08BU012026-05-18
06974500612848Rigid Uterine Aspiration CuretteGC7049B09BU012026-05-18
06974500612855Rigid Uterine Aspiration CuretteGC7049B10BU012026-05-18
06974500612862Rigid Uterine Aspiration CuretteGC7049B11BU012026-05-18
06974500612879Rigid Uterine Aspiration CuretteGC7049B12BU012026-05-18
06974500612886Rigid Uterine Aspiration CuretteGC7049B14BU012026-05-18
06974500612893Rigid Uterine Aspiration CuretteGC7049B16BU012026-05-18
06974500612909Rigid Uterine Aspiration CuretteGC7049E14BU012026-05-18
06974500613333Flexible Uterine Aspiration CuretteGC7049C04AU012026-05-18
06974500613340Flexible Uterine Aspiration CuretteGC7049C05AU012026-05-18
06974500613357Flexible Uterine Aspiration CuretteGC7049C06AU012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500612718Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612725Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612732Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612749Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612756Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612770Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612787Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612794Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612824Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612831Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612848Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612855Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612862Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612879Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612886Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612893Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612909Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613333Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613340Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613357Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613364Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613371Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
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