Impact

GUDID 00810135963275

PEEK Nail Cannulated 4.0mm drill. 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.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Cannulated surgical drill bit, reusable

• Primary Device ID: 00810135963275
• NIH Device Record Key: e8eb07bc-99f2-49d4-a6cd-2df577208ddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impact
• Version Model Number: PP-1000T-400
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com
• Phone: 210-598-5938
• Email: denisealva@nvisionbiomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135963275 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

[00810135963275]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Impact]

• 00810135964173: Impact PEEK Fusion Nail Case Assembly The Impact PEEK Union Nail System contains 3.0mm - 4.5mm d
• 00810135963626: Fusion-Grade PEEK Nail 4.0x50mm. The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diam
• 00810135963619: Fusion-Grade PEEK Nail 3.0x50mm. The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diame
• 00810135963381: PEEK Nail 2.0mm extraction drill. The Impact PEEK Union Nail System is indicated for maintenanc
• 00810135963275: PEEK Nail Cannulated 4.0mm drill. The Impact PEEK Union Nail System is indicated for maintenanc
• 00810135963251: PEEK Nail Cannulated 3.0mm drill. The Impact PEEK Union Nail System is indicated for maintenanc
• 00810135963183: Impact PEEK Union Nail 4.0 Inserter Shaft/PEEK Union Nail 4.0mm Inserter Sleeve The Impact PEEK
• 00810135963169: Impact PEEK Union Nail 3.0 Inserter Shaft/PEEK Union Nail3.0mm Inserter Sleeve The Impact PEEK U
• 00810135963343: PEEK Nail 4.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alig
• 00810135963336: PEEK Nail 3.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alig
• 00810135963657: Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation
• 00810135963640: Kwire 1.4mmx127mm single trocar The Impact PEEK Union Nail System is indicated for maintenance o
• 00810135963411: PEEK Nail Slap Hammer The Impact PEEK Union Nail System is indicated for maintenance of alignmen
• 00810135963404: Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment an
• 00810135963374: PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignme
• 00810135963329: PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignme
• 00810135963282: PEEK Union Nail 4.0 Countersink Shaft The Impact PEEK Union Nail System is indicated for mainten
• 00810135963268: PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for mainten