TRUCLEAR CALIBRATION INSERT 4.0

TRUCLEAR CALIBRATION INSERT 4.0
TRUCLEARTM Calibration Insert 4.0 - 72203606

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: HIH

Device Name: Hysteroscope (And Accessories)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.1690

Third Party Flag: Y

Medical Specialty: OB

Device Id: 00885554027600

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