- Physicians Office Resource

DEFINITY CERVICAL DILATOR, 5MM - DCD-501

Device Description

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.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

Ethylene Oxide

Ethylene Oxide

Product Codes

Code: PON

Device Name: Catheter, Balloon, Dilation Of Cervical Canal

Device Class: 2

Physical State: Catheter with inflatable balloons.

Definition: Mechanical dilation and softening of the cervix.

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: When placed in the cervical canal, the device uses mechanical force to dilate and soften the cervix.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cervical canal

Regulation Number: 884.4260

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 15420045512412

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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