Primary Device ID | 00889795140142 |
NIH Device Record Key | 727c5aa8-d251-4828-ac99-165b9b339991 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bun-Yo-Matic™ Lapidus Clamp System |
Version Model Number | P31-941-0100 |
Catalog Number | P31-941-0100 |
Company DUNS | 042961576 |
Company Name | PARAGON 28, INC. |
Device Count | 1 |
DM Exempt | false |
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 | 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 Issuing Agency | Device ID |
---|---|
GS1 | 00889795140142 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-21 |
Device Publish Date | 2024-06-13 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BUN-YO-MATIC 98109131 not registered Live/Pending |
Paragon 28, Inc. 2023-07-31 |