AccessGUDID - DEVICE: Sani ProZyme Enzymatic Detergent (00732224002903)

GUDID

Device Identifier (DI) Information

Brand Name: Sani ProZyme Enzymatic Detergent
Version or Model: JED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JED
Company Name: CROSSTEX INTERNATIONAL, INC.

Primary DI Number: 00732224002903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057728685 *Terms of Use

Device Description: 1 Gallon Bottle, Fresh Scent

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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
FLG	Cleaner, ultrasonic, medical instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf4e27de-b7de-4e94-ac3c-03d7f1297b4c
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023