AccessGUDID - DEVICE: Clear Choice (10620974002830)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Choice
Version or Model: SMI9210-100PF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMI9210-100PF
Company Name: Southmedic Incorporated

Primary DI Number: 10620974002830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: Eye Shields

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):	Yes
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
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

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: ff56fc02-ff67-4c16-8748-e69e015cd473
Public Version Date: October 12, 2020
Public Version Number: 1
DI Record Publish Date: October 02, 2020