Home GUDID 00850048720541 Speculum Kits
Primary DI 00850048720541
Brand Speculum Kits
Company Specialty Health Products, LLC
Model 1104
Device description 1104 - Disposable Standard 2-Piece Speculum Kit
Published 2026-07-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FFQ Speculum, Rectal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFQ Speculum, Rectal Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850048720541 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850048720541 00850048720541 850048720541 0850048720541
GMDN Terms# Term, Definition table Term Definition Colonic lavage kit, non-surgical A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.
Regulatory Flags# DUNS number 119446468 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B382SD917665100 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 B382SD917665110 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 B382SD917665120 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 B382SD917665700 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 B382SD917665920 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 B382SD917665930 Surgical Direct Surgical Direct, Inc. FFQ 2026-10-20 00190776433352 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433369 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433376 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433383 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433390 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433406 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433413 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433420 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433437 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433444 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433451 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433468 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433475 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433482 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433499 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 00190776433505 Millennium Avalign Technologies, Inc. FFQ 2026-10-05 G141554100200 Carnegie Surgical LLC Carnegie Surgical LLC FFQ 2026-09-30 00190776432362 Millennium Avalign Technologies, Inc. FFQ 2026-09-24 00860015748508 Thermora Anoscope OMEC Medical (NV) Inc. FFQ 2026-07-31 00190776422189 Millennium Avalign Technologies, Inc. FFQ 2026-07-28 00850048720619 Speculum Kits Specialty Health Products, LLC FFQ 2026-07-23 00850048720626 Speculum Kits Specialty Health Products, LLC FFQ 2026-07-23 00850048720633 Speculum Kits Specialty Health Products, LLC FFQ 2026-07-23 00850048720640 Speculum Kits Specialty Health Products, LLC FFQ 2026-07-23