AccessGUDID - DEVICE: Xerostom® Saliva Substitute Gel (08426181972769)

GUDID

Device Identifier (DI) Information

Brand Name: Xerostom® Saliva Substitute Gel
Version or Model: Tube 25ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIO COSMETICS SL

Primary DI Number: 08426181972769
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 513423178 *Terms of Use

Device Description: XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth

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?
37576	Artificial saliva	An electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFD	Saliva, Artificial

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
Special Storage Condition, Specify: Store at room temperature. Use within three months after first opening. Use before expiration date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23e244c1-03a3-4146-98ed-4d07bf5afe9f
Public Version Date: April 09, 2024
Public Version Number: 1
DI Record Publish Date: April 01, 2024