AccessGUDID - DEVICE: BioStom (00370275850250)

GUDID

Device Identifier (DI) Information

Brand Name: BioStom
Version or Model: BioStom 25ct
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Forward Science Technologies LLC

Primary DI Number: 00370275850250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079212068 *Terms of Use

Device Description: BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services.

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?
47943	General oral wound dressing, non-animal-derived	A compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by trauma, surgery, radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
OLR	Oral Wound Dressing

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: eda026dd-3e50-4819-8a97-6a13a0b6f4df
Public Version Date: February 22, 2024
Public Version Number: 1
DI Record Publish Date: February 14, 2024