AccessGUDID - DEVICE: Health-Tec Ultra Earloop Masks (D7734507000P21)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec Ultra Earloop Masks
Version or Model: 450-7000P2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 450-7000P2
Company Name: Dental Health Products Inc

Primary DI Number: D7734507000P21
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2019
Device Count: 50
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec Ultra Earloop Masks, Level 1, Pink

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":	Yes
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?
35177	Surgical/medical face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc0fb664-a898-449e-bc57-2c6201c924c3
Public Version Date: May 06, 2020
Public Version Number: 5
DI Record Publish Date: January 24, 2017