AccessGUDID - DEVICE: UNIWEB SURGICAL MASK (04715243610140)

GUDID

Device Identifier (DI) Information

Brand Name: UNIWEB SURGICAL MASK
Version or Model: ASTM Level 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UNIVERSAL INCORPORATION

Primary DI Number: 04715243610140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 656249554 *Terms of Use

Device Description: The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
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: 48cfb111-0c1b-445a-a136-716ebcf0523e
Public Version Date: December 12, 2022
Public Version Number: 2
DI Record Publish Date: January 03, 2022