GEM 21S

Basic Information

• Brand Name: GEM 21S
• Primary DI: D749210005201812047283
• Version / Model: N/A
• Company Name: LUITPOLD PHARMACEUTICALS, INC.
• Labeler DUNS: 002033710
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-27
• Public Version: 2
• Public Version Date: 2018-12-04
• Public Version Status: Update
• Public Device Record Key: a56d2bcb-4a0a-447a-8ef6-bde334ee3958
• Distribution End Date: 2018-12-04

Device Description

Growth-factor Enhanced Matrix for Periodontal Regeneration

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
45481	Periodontal root surface regeneration material	A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. It is typically presented in the form of a gel, or as a solution and enamel matrix material that is mixed into a gel prior to application. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D749210005201812047283	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]