MemGuide

Basic Information

• Brand Name: MemGuide
• Primary DI: 00812337020398
• Version / Model: 30076-01
• Catalog Number: 7351520
• Company Name: DSM BIOMEDICAL, INC.
• Labeler DUNS: 131107757
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-30
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 24e2a24b-a4ed-43fa-a71d-0d8a2cb0991d

Device Description

Porcine Dental Membrane

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPL	Barrier, Animal Source, Intraoral	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30076	Voice amplification system	An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812337020398	GS1

Device Sizes

Type	Value	Unit	Text
Length	20	Millimeter
Width	15	Millimeter