AccessGUDID - DEVICE: PerioStom (00370275090168)

GUDID

Device Identifier (DI) Information

Brand Name: PerioStom
Version or Model: PerioStom 16ct
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Forward Science Technologies LLC

Primary DI Number: 00370275090168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079212068 *Terms of Use

Device Description: PerioStom Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35573	Clinical periodontal dressing	A dental material intended to be used during periodontal procedures to facilitate periodontal tissue healing by providing mechanical, chemical, and/or thermal protection to wounded tissue after surgery or disease, and/or by functioning as a barrier for the prevention of bacterial infiltration in a periodontal pocket after root surface debridement (RSD) and/or planing and root scaling. Some types may adhere to teeth and gums and be used to secure medications, temporary prostheses, and loose teeth. It is available in various forms (e.g., gel in a syringe, fluid in a dispenser with mixing nozzle, substance mixed chairside into a pliable paste). 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

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: 1c556624-24b9-4030-965b-7bc3763bb1d5
Public Version Date: February 22, 2024
Public Version Number: 1
DI Record Publish Date: February 14, 2024