Impact

Basic Information

• Brand Name: Impact
• Primary DI: 00810135963404
• Version / Model: PP-1000T-DEP34
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 047486041
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-24
• Public Version: 1
• Public Version Date: 2025-10-02
• Public Version Status: New
• Public Device Record Key: 24c8621a-0938-4403-ac67-02b85686cbe0

Device Description

Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: No
• 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
HTJ	Gauge, Depth	Orthopedic	888.4300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32845	Surgical depth gauge, reusable	A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810135963404	GS1

Customer Contacts

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