Home GUDID 15420045512191 CERVICAL SEAL ASSY DEVICE
Primary DI 15420045512191
Brand CERVICAL SEAL ASSY DEVICE
Company Hologic, Inc.
Model OLK-100
Catalog number OLK-100
Device description The Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.
Published 2019-09-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QHZ Seal, cervical, mechanical, unpowered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QHZ Seal, Cervical, Mechanical, Unpowered Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25420045512198 Package GS1 5 In Commercial Distribution 35420045512195 Package GS1 5 In Commercial Distribution 45420045512192 Package GS1 5 In Commercial Distribution 15420045512191 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25420045512198 25420045512198 35420045512195 35420045512195 45420045512192 45420045512192 15420045512191 15420045512191
GMDN Terms# Term, Definition table Term Definition Hysteroscopy cervical leakage sheath 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.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 018925968 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# 
hologic.com