ENDOZIME INSTRUSPONGE 3mm (RIGID)

GUDID 00810929011311

brushes to clean medical instruments

Ruhof Corporation

Surgical instrument/endoscope cleaning utensil, single-use
Primary Device ID00810929011311
NIH Device Record Key643a46f0-478a-49f6-8e9e-de451ae4ad98
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOZIME INSTRUSPONGE 3mm (RIGID)
Version Model Number345ESS3R
Company DUNS082779828
Company NameRuhof Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810929010048 [Primary]
GS100810929011311 [Package]
Contains: 00810929010048
Package: case [100 Units]
In Commercial Distribution

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-18
Device Publish Date2025-07-10

Devices Manufactured by Ruhof Corporation

00810929011281 - ENDOZIME INSTRUSPONGE 1mm (RIGID)2025-07-18 brushes to clean medical instrument.
00810929011298 - ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 2025-07-18 BRUSHES FOR CLEANING OF MEDICAL INSTRUMENTS
00810929011519 - ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 2025-07-18 brushes to clean medical instrument
00810929011311 - ENDOZIME INSTRUSPONGE 3mm (RIGID) 2025-07-18brushes to clean medical instruments
00810929011311 - ENDOZIME INSTRUSPONGE 3mm (RIGID) 2025-07-18 brushes to clean medical instruments
00810929011526 - ENDOZIME INSTRUSPONGE 5mm (RIGID) 2025-07-18 brushes to clean the medical instrumnets
00810929011335 - ENDOZIME INSTRUSPONGE 7mm (RIGID) 2025-07-18 brushes to clean medical instruments.
00810929011342 - ENDOZIME INSTRUSPONGE 10mm (RIGID) 2025-07-18 brushes to clean medical instruments
00810929011359 - ENDOZIME INSTRUSPONGE 12mm (RIGID) 2025-07-18 brushes to clean the medical instruments

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