3000CC HI
N/A - 72200024
Device Description
A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KDQ
Device Name: Bottle, Collection, Vacuum
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.6740
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 23596010591504
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03596010591500
Package Quantity: 36
Package Discontinue Date: 8/8/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: BX
Device Id: 03596010591500
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