Special Instrument SP31-950-0004

GUDID 00889795151766

Special Instrument, Straight Nail Short Calc Screw Drill Guide

Paragon 28, Inc.

Surgical drill guide, reusable
Primary Device ID00889795151766
NIH Device Record Key1da6e1e5-a99b-4b5f-9f5c-91535aca71ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecial Instrument
Version Model NumberSP31-950-0004
Catalog NumberSP31-950-0004
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
GS100889795151766 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-17
Device Publish Date2025-07-09

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