Home GUDID B382SD9150471130 Surgical Direct
Primary DI B382SD9150471130
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD915047113
Catalog number SD915047113
Device description Graves Ebonized Speculum, One Smoke Tube, Extra Large, 15.0 cm x 4.0 cm Blades
Published 2026-07-28
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 HDF Speculum, Vaginal, Metal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HDF Speculum, Vaginal, Metal Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B382SD9150471130 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vaginal speculum, reusable A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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 00198506093845 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-29 00198506093852 ELMED ELMED INCORPORATED HDF 2026-07-29 00198506093142 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-28 00198506093265 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-28 00198506093272 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-28 00198506093418 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-28 B382SD915038100 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 B382SD915038110 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 B382SD915038120 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 B382SD915039110 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 B382SD9150471000 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 B382SD9150471140 Surgical Direct Surgical Direct, Inc. HDF 2026-07-28 00190776421939 Millennium Avalign Technologies, Inc. HDF 2026-07-23 00198506091964 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-22 00198506091995 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-22 00198506092008 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-22 00198506091803 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-10 00198506091827 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-10 00198506091834 ELMED INCORPORATED ELMED INCORPORATED HDF 2026-07-10 00850083275365 Intrace USA PILOTIS TECH LLC HDF 2026-07-03 00190776421632 Millennium Avalign Technologies, Inc. HDF 2026-06-23 00810158211360 PRINCETON Princeton Medical Group, Inc. HDF 2026-06-23 05060212052339 Cusco Specula Metal Small DTR MEDICAL LIMITED HDF 2026-06-10 05060212052346 Cusco Specula Metal Medium DTR MEDICAL LIMITED HDF 2026-06-10 05060212052360 Cusco Specula Metal Large DTR MEDICAL LIMITED HDF 2026-06-10 05060411982314 Cusco Specula Metal Large Long DTR MEDICAL LIMITED HDF 2026-06-10 05060411982321 Cusco Specula Metal Large Extra Long DTR MEDICAL LIMITED HDF 2026-06-10 05060411982369 Cusco Specula Metal Broad DTR MEDICAL LIMITED HDF 2026-06-10 05060411984462 Cusco Specula Metal Medium Long DTR MEDICAL LIMITED HDF 2026-06-10 05060411985117 Cusco Specula Metal Small XXLong DTR MEDICAL LIMITED HDF 2026-06-10
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