DEVICE: WomanCare Global Uterine Evacuation Kit (00853615006307)
Device Identifier (DI) Information
WomanCare Global Uterine Evacuation Kit
UEK-SU
In Commercial Distribution
WOMANCARE GLOBAL TRADING, INC.
UEK-SU
In Commercial Distribution
WOMANCARE GLOBAL TRADING, INC.
Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae : 6mm, 7mm, 8mm and 9 mm, 3 Denniston Dilators: 5/6mm, 7/8mm and 9/10 mm.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62162 | Abortion suction system manual aspirator |
A 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.
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Active | false |
47987 | Fixed-diameter cervical dilator, single-use |
A 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.
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Active | false |
47341 | Intrauterine curette, suction |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HHI | System, Abortion, Vacuum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Dilators : 5/6mm, 7/8mm, 9/10mm |
Device Size Text, specify: Cannulae : 223mm long and 0.5mm to 1.3mm in thickness |
Device Size Text, specify: Double Valve Aspirator : 9" long and 3.5" in diameter |
Device Record Status
e3046d4b-11ea-4940-8c91-3406a6b3a07f
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-858-314-4030
customerservice@womancareglobal.org
customerservice@womancareglobal.org