The Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.

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

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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