FirstPlug Alpha 2.0

Basic Information

• Brand Name: FirstPlug Alpha 2.0
• Primary DI: 00860005367245
• Version / Model: A000020-060
• Catalog Number: A20-060
• Company Name: 35newtons L.L.C.
• Labeler DUNS: 122626175
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-01
• Public Version: 2
• Public Version Date: 2025-07-02
• Public Version Status: Update
• Public Device Record Key: 95f91da7-2c2c-424a-b240-744aaea6e760

Device Description

FirstPlug Alpha 2.0 Screw Channel Barrier 300 cm

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64187	Antimicrobial dental prosthesis/implant plug	A small device intended to remain in place long-term (>30 days) and designed to plug the hole in a screw-retained crown or dental prosthesis abutment to prevent the penetration of cement, filling material or bacteria into the free space above the screw. It is in the form of an elongated cone typically made of polymer materials, and includes an antimicrobial agent (e.g., silver). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860005367245	GS1