AccessGUDID - DEVICE: MetriCide OPA Plus (00615375006436)

GUDID

Device Identifier (DI) Information

Brand Name: MetriCide OPA Plus
Version or Model: 10-6000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: METREX RESEARCH, LLC

Primary DI Number: 00615375006436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145963778 *Terms of Use

Device Description: orthoPhthalaldehyde Solution high level disinfectant for semicritical medical devices

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store original sealed containers at a controlled room temperature of 15 - 30

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Gallon

Device Record Status

Public Device Record Key: 87067a07-9795-4fcc-9549-76a6b1832af9
Public Version Date: April 04, 2023
Public Version Number: 7
DI Record Publish Date: August 31, 2016