AccessGUDID - DEVICE: Practicon Face Shields (00723896017654)

GUDID

Device Identifier (DI) Information

Brand Name: Practicon Face Shields
Version or Model: Practicon Face Shields
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7039733
Company Name: PRACTICON, INC.

Primary DI Number: 00723896017654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: The Protective Face Shield offers full-face protection with a soft, detachable elastic headband. 1 1/4" thick permanently adhered foam pad supports the antifog shield over most eyewear and loupes. Wash with soap and water and allow to air dry. 10 per 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?
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: 4a3e4ce6-e8a4-4b9f-93d5-61c6d983744c
Public Version Date: July 21, 2020
Public Version Number: 1
DI Record Publish Date: July 13, 2020