Bun-Yo-Matic™ Lapidus Clamp System P99-251-1604

GUDID 00889795131386

K-Wire, Olive, Threaded, Ø1.8mm x 4.7cm

PARAGON 28, INC.

Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use Orthopaedic guidewire, single-use

• Primary Device ID: 00889795131386
• NIH Device Record Key: 0075e508-9714-4420-b009-e5825c40a106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bun-Yo-Matic™ Lapidus Clamp System
• Version Model Number: P99-251-1604
• Catalog Number: P99-251-1604
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795131386 [Primary]

FDA Product Code

• HXI: PASSER, WIRE, ORTHOPEDIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [Bun-Yo-Matic™ Lapidus Clamp System]

• 00889795131393: Bun-Yo-Matic, Anti-Penetration Tool
• 00889795131379: Bun-Yo-Matic, Cuneiform Cut Guide, Right
• 00889795131362: Bun-Yo-Matic, Cuneiform Cut Guide, Left
• 00889795131355: Bun-Yo-Matic, Met Cut Guide, Right
• 00889795131348: Bun-Yo-Matic, Met Cut Guide, Left
• 00889795131331: Bun-Yo-Matic, Weight Bearing Wedge
• 00889795129420: 5mm Female Hex Driver
• 00889795129413: Lapidus Nail Tissue Protector, Rotated 90
• 00889795129383: Bun-Yo-Matic, Lateral Adjuster, Left
• 00889795129352: Bun-Yo-Matic, Tray, Base
• 00889795129284: Bun-Yo-Matic, Met Grip Wire Guide
• 00889795129277: Bun-Yo-Matic, Wire Tube
• 00889795129260: Bun-Yo-Matic, 1st Met Wire Guide
• 00889795129215: Bun-Yo-Matic, Lateral Hook
• 00889795129208: Bun-Yo-Matic, Lateral Adjuster, Right
• 00889795129192: Bun-Yo-Matic, Rotator, Right
• 00889795129185: Bun-Yo-Matic, Rotator, Left
• 00889795129055: Saw Blade 39 x 10 x 0.4/0.6mm, Stryker (Sterile)
• 00889795129048: Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile)
• 00889795114129: K-wire Tube, 150mm MAX
• 00889795131386: K-Wire, Olive, Threaded, Ø1.8mm x 4.7cm
• 00889795131324: Bun-Yo-Matic, K-wire, Ø2.30mm x 19cm, Smooth
• 00889795140142: K-wire Tube, 100mm MAX
• 00889795140135: K-wire Tube, 80mm MAX