AccessGUDID - DEVICE: Walgreens (00311917046877)

GUDID

Device Identifier (DI) Information

Brand Name: Walgreens
Version or Model: 630109
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SQN5494SB1
Company Name: WALGREEN CO.

Primary DI Number: 00311917046877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: Walgreens Dental Guard For Nighttime Teeth Grinding (Bruxism) 2 Dental Guards, 1 Storage Case, 1 Fitting Tray

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
38621	Mouthguard, reusable	A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBR	Mouthguard, Over-The-Counter

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: c7e700ac-44d3-48dc-9e1b-c1c47c774232
Public Version Date: January 26, 2024
Public Version Number: 1
DI Record Publish Date: January 18, 2024