Device
Russel-Davis Tongue Depressor 13.5 cm - 5 1/4" Blade Size 25 x 75 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
Model: OM-099-03 DI: 05055445974756 Status: New MRI: MR Conditional Single-use: No Rx: No OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Russel-Davis Tongue Depressor 13.5 cm - 5 1/4" Blade Size 25 x 75 mm Stainless Steel
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: cce07153-fd54-46a0-8751-62fadd2b1521
Distribution Status: In Commercial Distribution
DUNS Number: 216232502
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 05055445974756
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35085
Name: Mouth gag, adjustable, reusable
Definition:
A mechanical device with 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/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.
FDA Product Codes
LRC
INSTRUMENT, ENT MANUAL SURGICAL