Bun-Yo-Matic™ Lapidus Clamp System P31-941-0100

GUDID 00889795140142

K-wire Tube, 100mm MAX

PARAGON 28, INC.

Device sterilization/disinfection container, reusable
Primary Device ID00889795140142
NIH Device Record Key727c5aa8-d251-4828-ac99-165b9b339991
Commercial Distribution StatusIn Commercial Distribution
Brand NameBun-Yo-Matic™ Lapidus Clamp System
Version Model NumberP31-941-0100
Catalog NumberP31-941-0100
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795140142 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-21
Device Publish Date2024-06-13

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

00889795131393Bun-Yo-Matic, Anti-Penetration Tool
00889795131379Bun-Yo-Matic, Cuneiform Cut Guide, Right
00889795131362Bun-Yo-Matic, Cuneiform Cut Guide, Left
00889795131355Bun-Yo-Matic, Met Cut Guide, Right
00889795131348Bun-Yo-Matic, Met Cut Guide, Left
00889795131331Bun-Yo-Matic, Weight Bearing Wedge
008897951294205mm Female Hex Driver
00889795129413Lapidus Nail Tissue Protector, Rotated 90
00889795129383Bun-Yo-Matic, Lateral Adjuster, Left
00889795129352Bun-Yo-Matic, Tray, Base
00889795129284Bun-Yo-Matic, Met Grip Wire Guide
00889795129277Bun-Yo-Matic, Wire Tube
00889795129260Bun-Yo-Matic, 1st Met Wire Guide
00889795129215Bun-Yo-Matic, Lateral Hook
00889795129208Bun-Yo-Matic, Lateral Adjuster, Right
00889795129192Bun-Yo-Matic, Rotator, Right
00889795129185Bun-Yo-Matic, Rotator, Left
00889795129055Saw Blade 39 x 10 x 0.4/0.6mm, Stryker (Sterile)
00889795129048Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile)
00889795114129K-wire Tube, 150mm MAX
00889795131386K-Wire, Olive, Threaded, Ø1.8mm x 4.7cm
00889795131324Bun-Yo-Matic, K-wire, Ø2.30mm x 19cm, Smooth
00889795140142K-wire Tube, 100mm MAX
00889795140135K-wire Tube, 80mm MAX

Trademark Results [Bun-Yo-Matic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BUN-YO-MATIC
BUN-YO-MATIC
98109131 not registered Live/Pending
Paragon 28, Inc.
2023-07-31

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