The Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.
CERVICAL SEAL ASSY DEVICE - OLK-100
Device Description
A sterile tubular cover designed to be fitted on the invasive distal end of a hysteroscope to increase its diameter and thus reduce fluid leakage between the cervix and endoscope during hysteroscopic procedures. It is made of a soft synthetic polymer (e.g., silicone) which conforms to the internal surface of the cervix. 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: False
Sterilization Methods: No Data Available
Product Codes
Code: QHZ
Device Name: Seal, Cervical, Mechanical, Unpowered
Device Class: 1
Physical State: These devices attach to the hysteroscope or sheath and contacts the cervix and forms a seal. They may be passive or may have simple mechanical action (e.g., springs) that facilitate contact between the distal tip and cervix to promote the seal.
Definition: Reduce fluid leakage from the cervix during hysteroscopic procedures.
Submission Type ID: 4
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: These devices are simple mechanical devices that attach to a hysteroscope and form a physical seal between the hysteroscope and the cervix. The mechanical seal reduces leakage from the cervix during hysteroscopic procedures.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Vagina, cervix, uterus
Regulation Number: 884.1690
Third Party Flag: N
Medical Specialty: OB
Device Identifiers
Device Id: 15420045512191
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: 25420045512198
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045512191
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 35420045512195
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045512198
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 45420045512192
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35420045512195
Package Quantity: 32
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
