FDA.reportPublic FDA data

WomanCare Global 3mm Cannula

Primary DI
00853615006284
Brand
WomanCare Global 3mm Cannula
Company
WOMANCARE GLOBAL TRADING, INC.
Model
EB3
Device description
3mm outside diameter, product code EB3. The device is flexible and manufactured from a copolyester plastic and is approximately 23 cm long. The cannula has a light blue winged proximal grip with two opposing apertures at the distal end. A sterile, single-use device, packed in a Tyvek-film pouch, which is heat sealed.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00853615006284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853615006284008536150062848536150062840853615006284

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine cannula, single-useA sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store dry instruments at room temperature, in a clean dry container protected from contaminants, in an environment that preserves the level of processing desired.

Contacts#

Phone, Email table
PhoneEmail
+1-540-375-9380reporting@womancareglobal.org
+1-540-375-9380qara@dktwomancare.org

Regulatory Flags#

DUNS number
064730456
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853615006338WomanCare Global 6mm AdapterADP-6MM2016-09-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011927662Monarch Medical ProductsBioteque Taiwan Ltd.HHK2026-07-24
04719894436487LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436494LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436500LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
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
06974500612763Rigid 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
00810142352338Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
00810142352369Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
04719894432335BiotequeBioteque Taiwan Ltd.HHK2024-12-06