Home GUDID H8342200 Integra® Miltex®
Primary DI H8342200
Brand Integra® Miltex®
Company INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model 2-20
Catalog number 2-20
Device description Maunder Oral Screw, White Plastic
Published 2018-09-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KBW SCREW, ORAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KBW Screw, Oral Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780506492 Primary GS1 0 H8342200 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780506492 10381780506492
GMDN Terms# Term, Definition table Term Definition Mouth gag, non-adjustable A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081277700 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04719872108795 Teeth Screw Driver ENTER MEDICAL CORPORATION KBW 2023-06-19 10381780506492 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION KBW 2018-09-12
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