AccessGUDID - DEVICE: Primera Medical Supplies (10850018739044)

GUDID

Device Identifier (DI) Information

Brand Name: Primera Medical Supplies
Version or Model: FACE SHIELD-Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FACE SHIELD-Y
Company Name: PRIMERA PLASTICS, INC.

Primary DI Number: 10850018739044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 836290700 *Terms of Use

Device Description: Youth Size Disposable Face Shield - Anti Fog

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?
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. 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: d69254bf-d817-4376-b103-0b0aaae15068
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020