DEFINITY CERVICAL DILATOR, 7MM - DCD-701
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
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 IdentifiersDevice Id: 25420045512426
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045512429
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15420045512429
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
Device Id: 25420045512457
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045512429
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 35420045512423
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045512426
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 35420045512454
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045512457
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX