FDA.reportPublic FDA data

WomanCare Global 6mm Adapter

Primary DI
00853615006338
Brand
WomanCare Global 6mm Adapter
Company
WOMANCARE GLOBAL TRADING, INC.
Model
ADP-6MM
Device description
Adapters are packed in a sealed bag containing five 6mm adapters, blue in color. Adapters are compatible with the WomanCare Global Ipas MVA Plus® Aspirator. Adapters have wings for facilitation of adding and removing from aspirator. Adapters can be reused a maximum of 25 times.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGHCannula, Suction, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGHCannula, Suction, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853615006338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853615006338008536150063388536150063380853615006338

GMDN Terms#

Term, Definition table
TermDefinition
Abortion suction system manual aspiratorA non-sterile, manual, syringe-like device intended to be used in conjunction with an intrauterine cannula (not included) to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy. It includes a plunger with syringe barrel and appropriate connectors, seals, and valves, whereby fluid is intended to be aspirated directly into the barrel (i.e., not via a collection bottle). This is a reusable device after appropriate cleaning/disinfection.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Liquid Chemical"", ""High-level Disinfectant""]"
Moist Heat or Steam Sterilization;Liquid Chemical;High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+1-858-314-4030customerservice@womancareglobal.org

Regulatory Flags#

DUNS number
064730456
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853615006000WomanCare Global Flexible Karman Cannula, 10mmFC102016-09-17
00853615006024WomanCare Global Flexible Karman Cannula, 12mmFC122016-09-17
00853615006031WomanCare Global Flexible Karman Cannula, 4mm FC42016-09-17
00853615006048WomanCare Global Flexible Karman Cannula, 5mmFC52016-09-17
00853615006055WomanCare Global Flexible Karman Cannula, 6mmFC62016-09-17
00853615006062WomanCare Global Flexible Karman Cannula, 7mmFC72016-09-17
00853615006079WomanCare Global Flexible Karman Cannula, 8mmFC82016-09-17
00853615006086WomanCare Global Flexible Karman Cannula, 9mmFC92016-09-17
00853615006093WomanCare Global Ipas EasyGrip® Cannula, 10mmSR102016-09-17
00853615006109WomanCare Global Ipas EasyGrip® Cannula, 10mmSR10-SU2016-09-17
00853615006116WomanCare Global Ipas EasyGrip® Cannula, 12mmSR122016-09-17
00853615006123WomanCare Global Ipas EasyGrip® Cannula, 12mmSR12-SU2016-09-17
00853615006130WomanCare Global Ipas EasyGrip® Cannula, 4mmSR42016-09-17
00853615006147WomanCare Global Ipas EasyGrip® Cannula, 4mmSR4-SU2016-09-17
00853615006154WomanCare Global Ipas EasyGrip® Cannula, 5mmSR52016-09-17
00853615006161WomanCare Global Ipas EasyGrip® Cannula, 5mmSR5-SU2016-09-17
00853615006178WomanCare Global Ipas EasyGrip® Cannula, 6mmSR62016-09-17
00853615006185WomanCare Global Ipas EasyGrip® Cannula, 6mmSR6-SU2016-09-17
00853615006192WomanCare Global Ipas EasyGrip® Cannula, 7mmSR72016-09-17
00853615006208WomanCare Global Ipas EasyGrip® Cannula, 7mmSR7-SU2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946332802131GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802193GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802254GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802117GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802148GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802209GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
06946332802261GynoVisionChongqing Jinshan Science & Technology (Group) Co., LtdHGH2020-09-01
04715309124758NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124765NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124772NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124789NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124802NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124819NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124826NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124833NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124840NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124857NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124864NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124871NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124888NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125274NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125281NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125298NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125304NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309124796NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125328NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125335NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125342NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125359NAPANPAC MEDICAL CORPORATIONHGH2017-05-10
04715309125366NAPANPAC MEDICAL CORPORATIONHGH2017-05-10