Monkey Rings External Fixation System P45-194-2040

GUDID 00889795115263

Wire, Ø2.0 x 400 Smooth, Half Point

PARAGON 28, INC.

Orthopaedic bone wire
Primary Device ID00889795115263
NIH Device Record Key4acbd116-00d4-460c-a984-3ed0340be8b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonkey Rings External Fixation System
Version Model NumberP45-194-2040
Catalog NumberP45-194-2040
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100889795115263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-04
Device Publish Date2023-03-27

On-Brand Devices [Monkey Rings External Fixation System]

00889795124326Drill Guide for 6mm Half Pin Drill
00889795124319Drill Guide for 5mm Half Pin Drill
00889795124302Drill Guide for 4mm Half Pin Drill
00889795116468Ratchet Wrench, 10mm (OIC wrench)
00889795115287Wire, Ø2.0 x 400 Reduction, Half Point
00889795115263Wire, Ø2.0 x 400 Smooth, Half Point

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.