Home GUDID B382SD919064050 Surgical Direct
Primary DI B382SD919064050
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD91906405
Catalog number SD91906405
Device description #5 Davis-Boyle Mouth Gag Blade, 25 x 20mm
Published 2022-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FGN RETRACTOR, NON-SELF-RETAINING
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGN Retractor, Non-Self-Retaining Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B382SD919064050 Primary HIBCC 0
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 124367223 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 09348811023018 INKA The Trustee for KAISER FAMILY TRUST FGN 2026-03-16 B382SD1471020010 Surgical Direct Surgical Direct, Inc. FGN 2026-02-16 B382SD934117790 Surgical Direct Surgical Direct, Inc. FGN 2025-09-17 B382SD934117800 Surgical Direct Surgical Direct, Inc. FGN 2025-09-17 B382SD934117810 Surgical Direct Surgical Direct, Inc. FGN 2025-09-17 B382SD934117820 Surgical Direct Surgical Direct, Inc. FGN 2025-09-17 B382SD934117830 Surgical Direct Surgical Direct, Inc. FGN 2025-09-17 B382SD711510000 Surgical Direct Surgical Direct, Inc. FGN 2025-08-11 B382SD722510000 Surgical Direct Surgical Direct, Inc. FGN 2025-08-11 B382SD914781140 Surgical Direct Surgical Direct, Inc. FGN 2025-07-23 B382SD914173650 Surgical Direct Surgical Direct, Inc. FGN 2025-07-10 B382SD91417810000 Surgical Direct Surgical Direct, Inc. FGN 2025-07-10 B382SD91417810010 Surgical Direct Surgical Direct, Inc. FGN 2025-07-10 B382SD91417811010 Surgical Direct Surgical Direct, Inc. FGN 2025-07-10 B382SD9141801050 Surgical Direct Surgical Direct, Inc. FGN 2025-07-10 B382SD4834150 Surgical Direct Surgical Direct, Inc. FGN 2025-07-02 B382SD4861300 Surgical Direct Surgical Direct, Inc. FGN 2025-07-02 B382SD4861400 Surgical Direct Surgical Direct, Inc. FGN 2025-07-02 B382SD4862150 Surgical Direct Surgical Direct, Inc. FGN 2025-07-02 B382SD4871160 Surgical Direct Surgical Direct, Inc. FGN 2025-07-02 00810123209361 Adler Instrument Company Adler, Inc. FGN 2025-05-23 B382SD147091530 Surgical Direct Surgical Direct, Inc. FGN 2025-04-07 B382SD9190691000 Surgical Direct Surgical Direct, Inc. FGN 2025-04-07 B382SD9190691010 Surgical Direct Surgical Direct, Inc. FGN 2025-04-07 B382SD9190691020 Surgical Direct Surgical Direct, Inc. FGN 2025-04-07 B382SD9190691030 Surgical Direct Surgical Direct, Inc. FGN 2025-04-07 B382SD1417812200 Surgical Direct Surgical Direct, Inc. FGN 2025-02-20 B382SD1417812310 Surgical Direct Surgical Direct, Inc. FGN 2025-02-20 00840319757611 Hayden Medical Hayden Medical, Inc. FGN 2025-01-10 00840319757628 Hayden Medical Hayden Medical, Inc. FGN 2025-01-10
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