Monkey Rings External Fixation System P45-194-2040

GUDID 00889795115263

Wire, Ø2.0 x 400 Smooth, Half Point

PARAGON 28, INC.

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Primary Device ID	00889795115263
NIH Device Record Key	4acbd116-00d4-460c-a984-3ed0340be8b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Monkey Rings External Fixation System
Version Model Number	P45-194-2040
Catalog Number	P45-194-2040
Company DUNS	042961576
Company Name	PARAGON 28, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	00889795115263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212895

FDA Product Code

KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-04
Device Publish Date	2023-03-27

On-Brand Devices [Monkey Rings External Fixation System]

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