Home GUDID 35420045512430 DEFINITY CERVICAL DILATOR, 9MM
Primary DI 35420045512430
Brand DEFINITY CERVICAL DILATOR, 9MM
Company Hologic, Inc.
Model DCD-901
Catalog number DCD-901
Published 2020-02-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PON Catheter, balloon, dilation of cervical canal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PON Catheter, Balloon, Dilation Of Cervical Canal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25420045512433 Package GS1 5 In Commercial Distribution 25420045512464 Package GS1 1 In Commercial Distribution 35420045512430 Package GS1 5 In Commercial Distribution 35420045512461 Package GS1 1 In Commercial Distribution 15420045512436 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25420045512433 25420045512433 25420045512464 25420045512464 35420045512430 35420045512430 35420045512461 35420045512461 15420045512436 15420045512436
GMDN Terms# Term, Definition table Term Definition Cervical dilatation catheter A flexible, tube-like device, typically with two or more inflatable balloons at the distal working end, designed to dilate (stretch open) the cervical canal after insertion through the cervical os and expansion of the balloons to assist in obstetrical or gynaecological procedures. It may be used for labour induction, spontaneously occurring labour, non-progressive labour, cervical dystocia, undesirable prolonged uterine contractions, and intrauterine foetal death (IUFD) where delivery of the foetus is difficult. Such procedures may be performed at or prior to full-term pregnancy. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 018925968 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 15420045512412 DEFINITY CERVICAL DILATOR, 5MM Hologic, Inc. PON 2020-02-05 15420045512429 DEFINITY CERVICAL DILATOR, 7MM Hologic, Inc. PON 2020-02-05 15420045512436 DEFINITY CERVICAL DILATOR, 9MM Hologic, Inc. PON 2020-02-05 35420045512416 DEFINITY CERVICAL DILATOR, 5MM Hologic, Inc. PON 2020-02-05 25420045512426 DEFINITY CERVICAL DILATOR, 7MM Hologic, Inc. PON 2020-02-05