WomanCare Global Flexible Karman Cannula, 5mm

GUDID 00853615006048

A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of the cannula. The cannulae are color-coded and use adapters with the same color-coding. This is a single-use device, sealed into packaging and sterilized.

WOMANCARE GLOBAL TRADING, INC.

Intrauterine curette, suction
Primary Device ID00853615006048
NIH Device Record Keyb672bc84-daa8-4b40-a44f-43636e6d128f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWomanCare Global Flexible Karman Cannula, 5mm
Version Model NumberFC5
Company DUNS064730456
Company NameWOMANCARE GLOBAL TRADING, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-858-314-4030
Emailcustomerservice@womancareglobal.org

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853615006048 [Primary]

FDA Product Code

HGHCannula, Suction, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-17

Devices Manufactured by WOMANCARE GLOBAL TRADING, INC.

00853615006000 - WomanCare Global Flexible Karman Cannula, 10mm2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator
00853615006024 - WomanCare Global Flexible Karman Cannula, 12mm2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator
00853615006031 - WomanCare Global Flexible Karman Cannula, 4mm 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannula feature dots as indicators for mea
00853615006048 - WomanCare Global Flexible Karman Cannula, 5mm2018-03-29A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of the cannula. The cannulae are color-coded and use adapters with the same color-coding. This is a single-use device, sealed into packaging and sterilized.
00853615006048 - WomanCare Global Flexible Karman Cannula, 5mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006055 - WomanCare Global Flexible Karman Cannula, 6mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006062 - WomanCare Global Flexible Karman Cannula, 7mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006079 - WomanCare Global Flexible Karman Cannula, 8mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006086 - WomanCare Global Flexible Karman Cannula, 9mm2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator
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