Home GUDID 00853227708002 LUMINELLE DTx 360 Rotatable Disposable Sheaths
Primary DI 00853227708002
Brand LUMINELLE DTx 360 Rotatable Disposable Sheaths
Company UVISION 360, INC.
Model LUMDTx-360
Catalog number 20020
Published 2019-05-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use false Product Codes# Code, Name table Code Name HIH Hysteroscope (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIH Hysteroscope (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10853227708009 Package GS1 1 In Commercial Distribution 00853227708002 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 10853227708009 10853227708009 00853227708002 00853227708002 853227708002 0853227708002
GMDN Terms# Term, Definition table Term Definition Endoscope sheath, single-use A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -10 Degrees Celsius 60 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080826327 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00853277008107 LUMINELLE Aspirator LUM-A 20081 2024-02-29 10853277008104 LUMINELLE Aspirator LUM-A 20081 2024-02-29 00853277008084 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 UP 20080 2021-08-13 00853277008091 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN 20085 2021-08-13 10853277008081 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 UP 20080 2021-08-13 10853277008098 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN 20085 2021-08-13 00853277008060 LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) LUMDx-360 20070 2019-11-07 00853277008053 LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath LUMDTx-360R 20060 2019-06-17 00853277008008 LUMINELLE DTx 360 Rotatable Disposable Sheaths LUMDTx-360 20020 2019-05-30 00853277008015 Uvision Hysteroscope LUMDTx-A1 20010 2019-05-30 00853277008022 Uvision Hysteroscope Cable 20050 2019-05-30 00853277008039 Luminelle DTx Control Hub 20012 2019-05-30 00853277008046 LUMINELLE DTx Hysteroscopy System LumDTX-A 20030 2019-05-30 10853277008050 LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath LUMDTx-360R 20060 2019-06-17 10853227708054 LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath LUMDTx-360R 20060 2019-06-17 00853227708019 Uvision Hysteroscope LUMDTx-A1 20010 2019-05-30 00853227708026 Uvision Hysteroscope Cable 20050 2019-05-30 00853227708033 Luminelle DTx Control Hub 20012 2019-05-30 00853227708040 LUMINELLE DTx Hysteroscopy System LumDTX-A 20030 2019-05-30
Other Devices Sharing Product Codes#