AccessGUDID - DEVICE: Plasdent UltraProof Earloop Mask (D832MK32)

GUDID

Device Identifier (DI) Information

Brand Name: Plasdent UltraProof Earloop Mask
Version or Model: MK2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MK3-2
Company Name: PLASDENT CORPORATION

Primary DI Number: D832MK32
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190377184 *Terms of Use

Device Description: DuralProof(TM) Earloop Face Mask - Blue (40pcs/box)

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?
57792	Surgical/medical respirator, antimicrobial	A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133070	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51c87726-86e2-4e5e-a90b-a346fccd65be
Public Version Date: September 13, 2023
Public Version Number: 5
DI Record Publish Date: September 21, 2018