AccessGUDID - DEVICE: ProCide-D Plus (00615375005545)

GUDID

Device Identifier (DI) Information

Brand Name: ProCide-D Plus
Version or Model: 10-3265
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: METREX RESEARCH, LLC

Primary DI Number: 00615375005545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145963778 *Terms of Use

Device Description: Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 3.4% Glutaraldehyde

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?
40579	Glutaraldehyde device sterilant	A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.	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 at Ambient Temperature

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Quart

Device Record Status

Public Device Record Key: aef1ed73-ef49-4f5a-8587-0166c261fd6c
Public Version Date: September 10, 2021
Public Version Number: 3
DI Record Publish Date: August 31, 2016