AccessGUDID - DEVICE: Clear-All Face Shield (00723896017678)

GUDID

Device Identifier (DI) Information

Brand Name: Clear-All Face Shield
Version or Model: 701787
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 701787
Company Name: PRACTICON, INC.

Primary DI Number: 00723896017678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Finally, there is a face shield specifically designed to fit over loupes and headlamps. The Clear-All Face Shield is super lightweight and comfortable with ample forward clearance. Black hook-and-loop headband doubles as forehead pad. Entire shield can be washed and reused. Antifog PET construction. 12" long with extended wraparound protection. Eight complete shields 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?
11961	Face splash shield, single-use	A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

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: f07f0c02-e2ef-40dd-846e-bf17a4032a7f
Public Version Date: November 24, 2020
Public Version Number: 1
DI Record Publish Date: November 16, 2020