FDA.reportPublic FDA data

WomanCare Global Miscarriage Management Kit

Primary DI
00853615006291
Brand
WomanCare Global Miscarriage Management Kit
Company
WOMANCARE GLOBAL TRADING, INC.
Model
MMK-SU
Device description
Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae: 6mm, 7mm, 8mm, and 9mm, 3 Denniston Dilators: 5/6mm, 7/8mm, and 9/10mm.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHISystem, Abortion, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHISystem, Abortion, VacuumObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853615006291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853615006291008536150062918536150062910853615006291

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, single-useA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064730456
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
GYNX31301GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31351GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31300GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31350GynexGYNEX CORPORATIONHHI2023-12-26
04055207040027NARichard Wolf GmbHHHI2022-10-27
M803022721MedGyn Pipette MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022730MedGyn Pipette IV MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022734MedGyn Pipette IIMEDGYN PRODUCTS, INC.HHI2020-12-14
00821925030862Gyrus ACMIGyrus ACMI, LLCHHI2017-05-10
00821925000247003997-901 Gauze Sack and O-RingGyrus Acmi, Inc.HHI2017-05-10
00821925009561GYRUS ACMIGyrus ACMI, LLCHHI2017-05-09
00821925010475BERKELEYGyrus ACMI, LLCHHI2016-10-18
00821925008632Berkeley 1/2" Collection SetGyrus Acmi, Inc.HHI2016-10-13
00821925008625BERKELEY 1/2" (13mm) PRIMARYGyrus Acmi, Inc.HHI2016-10-13
00821925004184Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 fGyrus Acmi, Inc.HHI2016-10-11
00821925000919VACURETTE CURVED 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
0082192500094021163 Permeable Gauze Sacks (10/Pkg)Gyrus Acmi, Inc.HHI2016-10-11
00821925000964VACURETTE STRAIGHT 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000971VACURETTE STRAIGHT 10MM 10PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000988VACURETTE STRAIGHT 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000995VACURETTE STRAIGHT 12MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001015VACURETTE CURVED 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001022VACURETTE CURVED 10MMGyrus Acmi, Inc.HHI2016-10-11
00821925001039VACURETTE CURVED 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001046VACURETTE CURVED 12MM-10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004689VACURETTE STRAIGHT 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004702VACURETTE CURVED 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004719VACURETTE STRAIGHT 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004726VACURETTE "F" TIP 4MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004597VACURETTE "F" TIP 5MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11