AccessGUDID - DEVICE: Walgreens (00311917211350)

GUDID

Device Identifier (DI) Information

Brand Name: Walgreens
Version or Model: 508933
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WALGREEN CO.

Primary DI Number: 00311917211350
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 16
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: READY TO WEAR DENTAL GUARD 16 CT.

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:	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: fbee6509-e032-4a19-a641-6dde43122a9d
Public Version Date: June 02, 2025
Public Version Number: 4
DI Record Publish Date: May 28, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10311917211357	48	20311917211354		In Commercial Distribution	Case
20311917211354	4	00311917211350		In Commercial Distribution	Inner

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 80311917211356 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-925-4733
Email: consumerrelations.pq@walgreens.com

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