AccessGUDID - DEVICE: Wavicide-01 (M44501041GL0)

GUDID

Device Identifier (DI) Information

Brand Name: Wavicide-01
Version or Model: 0104-1gl
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0104-1gl
Company Name: MEDICAL CHEMICAL CORPORATION

Primary DI Number: M44501041GL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008496861 *Terms of Use

Device Description: Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.

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):	Yes
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?
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 [?]
K914749	000

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: Do Not Freeze
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a989fcb-1dbd-40fb-982b-b420d39cb356
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016