AccessGUDID - DEVICE: Gemini Twin Cleaning Pads with enzymatic detergent (00843356100716)

GUDID

Device Identifier (DI) Information

Brand Name: Gemini Twin Cleaning Pads with enzymatic detergent
Version or Model: GP120Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356100716
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: Gemini Twin Cleaning Pads with enzymatic detergent - 2 Pairs of Pads per Pack

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?
61965	Medical device cleaning sponge/set	A hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08d93809-1f3e-40ca-b19e-0a86f0a4e305
Public Version Date: July 08, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020