Small Bone Phantom Intramedullary Nail System P30-L1-5558

GUDID 00889795038906

Lapidus Nail, Left, 58mm

PARAGON 28, INC.

Arthrodesis nail, non-sterile
Primary Device ID00889795038906
NIH Device Record Keyc0eaecf1-105a-4599-b7c5-a990f644dd5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Bone Phantom Intramedullary Nail System
Version Model NumberP30-L1-5558
Catalog NumberP30-L1-5558
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795038906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795038906]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

On-Brand Devices [Small Bone Phantom Intramedullary Nail System]

00889795055170Lapidus Cut Guide Caddy Lid
00889795055163MET-CUNEIFORM GUIDE, RIGHT 6°
00889795055156MET-CUNEIFORM GUIDE, RIGHT 2°
00889795055149MET-CUNEIFORM GUIDE, LEFT 6°
00889795055132MET-CUNEIFORM GUIDE, LEFT 4°
00889795055125MET-CUNEIFORM GUIDE, LEFT 2°
00889795055118Lapidus Cut Guide Caddy II
00889795055101MET-CUNEIFORM GUIDE, RIGHT 4°
00889795055095MIS Lapidus, Burr Guide
00889795055088MIS Lapidus, Burr Guide, Paddle
00889795055071MIS Lapidus, Flute Cleaner
00889795055064MIS Lapidus Burr Guide Caddy
00889795052933Lapidus Nail, 3-Hole, Right, 60mm
00889795052926Lapidus Nail, 3-Hole, Right, 58mm
00889795052919Lapidus Nail, 3-Hole, Right, 56mm
00889795052902Lapidus Nail, 3-Hole, Right, 54mm
00889795052896Lapidus Nail, 3-Hole, Right, 52mm
00889795052889Lapidus Nail, 3-Hole, Right, 50mm
00889795052872Lapidus Nail, 3-Hole, Right, 48mm
00889795052865Lapidus Nail, 3-Hole, Right, 46mm
00889795052858Lapidus Nail, 3-Hole, Right, 44mm
00889795052841Lapidus Nail, 3-Hole, Right, 42mm
00889795052834Lapidus Nail, 3-Hole, Right, 40mm
00889795052827Lapidus Nail, 3-Hole, Right, 38mm
00889795052810Lapidus Nail, 3-Hole, Left, 60mm
00889795052803Lapidus Nail, 3-Hole, Left, 58mm
00889795052797Lapidus Nail, 3-Hole, Left, 56mm
00889795052780Lapidus Nail, 3-Hole, Left, 54mm
00889795052773Lapidus Nail, 3-Hole, Left, 52mm
00889795052766Lapidus Nail, 3-Hole, Left, 50mm
00889795052759Lapidus Nail, 3-Hole, Left, 48mm
00889795052742Lapidus Nail, 3-Hole, Left, 46mm
00889795052735Lapidus Nail, 3-Hole, Left, 44mm
00889795052728Lapidus Nail, 3-Hole, Left, 42mm
00889795052711Lapidus Nail, 3-Hole, Left, 40mm
00889795052544Lapidus Nail, 2.75mm Wire Depth Gauge
00889795052537Lapidus Nail, Tissue Protector
00889795052520Lapidus Nail, Torque Indicating Driver, T10
00889795052513PHANTOM Nail, Tube Cap, Sphere Wire
00889795052506PHANTOM Nail, Tube Cap, Standard
00889795052490PHANTOM Nail, Sphere Wire Tube
00889795052483PHANTOM Nail, 2.3mm K-Wire Tube
00889795052476PHANTOM Nail, 2.0mm K-Wire Tube
00889795052469PHANTOM Nail, 1.6mm K-Wire Tube
00889795052452PHANTOM Screw Caddy Base
00889795052445PHANTOM Screw Caddy Lid
00889795052438PHANTOM Nail Caddy Base
00889795052421PHANTOM Nail Caddy Lid
00889795052414PHANTOM Instrument Tray
00889795052407PHANTOM Case Lid
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