Home GUDID 00888937003307 Dilateria
Primary DI 00888937003307
Brand Dilateria
Company Coopersurgical, Inc.
Model MX210
Device description Kit contents: One dilateria, thin (3mm), 2 gauze sponge envelopes and IFU
Published 2016-09-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HDY Dilator, Cervical, Hygroscopic-Laminaria
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HDY Dilator, Cervical, Hygroscopic-Laminaria Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 60888937003309 Package GS1 1 Not in Commercial Distribution 00888937003307 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 60888937003309 60888937003309 00888937003307 00888937003307 888937003307 0888937003307
GMDN Terms# Term, Definition table Term Definition Hygroscopic cervical dilator A sterile plug of expansible material intended to dilate the uterine cervix by gradually swelling to several times its original diameter through the absorption of moisture from the cervix over a period of several hours (typically <24 hours). It is made of synthetic polymer and/or plant-derived materials and typically has features (e.g., attached cord, handle) intended to assist anchoring, locating, and easy removal. The device is typically used to dilate the cervical canal for uterine curettage, labour induction, midterm abortions, intrauterine device (IUD) placement and removal, and radium placement. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 3 Millimeter
Regulatory Flags# DUNS number 801895244 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06974213565783 Malibu WENZHOU TIDE-OPTICAL CO.,LTD HDY 2026-04-13 GYNX161031 Laminaria GYNEX CORPORATION HDY 2017-01-19 GYNX161041 Laminaria GYNEX CORPORATION HDY 2017-01-19 GYNX161051 Laminaria GYNEX CORPORATION HDY 2017-01-19 00888937003314 Dilateria Coopersurgical, Inc. HDY 2016-09-20 00888937003321 Dilateria Coopersurgical, Inc. HDY 2016-09-20 00888937003338 Dilateria Coopersurgical, Inc. HDY 2016-09-20 60888937003309 Dilateria Coopersurgical, Inc. HDY 2016-09-20 60888937003316 Dilateria Coopersurgical, Inc. HDY 2016-09-20 60888937003323 Dilateria Coopersurgical, Inc. HDY 2016-09-20 60888937003330 Dilateria Coopersurgical, Inc. HDY 2016-09-20 M803021002 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021003 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021004 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021005 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021006 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021008 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021010 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021014 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021015 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021016 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021018 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021022 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021023 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021024 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021025 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29 M803021026 MedGyn Laminaria MEDGYN PRODUCTS, INC. HDY 2016-08-29