ACUMED

Basic Information

• Brand Name: ACUMED
• Primary DI: 10806378116704
• Version / Model: PL-PTACK-S
• Company Name: Acumed LLC
• Labeler DUNS: 196884852
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-05
• Public Version: 1
• Public Version Date: 2024-07-15
• Public Version Status: New
• Public Device Record Key: 5bb8e599-1bf8-493d-88d4-551ce1d0c87d

Device Description

Plate Tack

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47746	Bone tack inserter, basic	A hand-held manual surgical instrument designed to drive (insert) a tack into bone, typically to fixate an orthopaedic plate or sheet. It is typically formed with a shaft made of high-grade stainless steel and a handle at the proximal end made of metal or synthetic material. The distal end is designed to hold (grip) the head of the tack head during insertion, typically through a hole in the plate or sheet and into a pre-drilled hole in the bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10806378116704	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233311	000