AMDT Mini-Rail M725

GUDID 00855967006387

Flexible Rail

ARROWHEAD DE LLC

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00855967006387
NIH Device Record Key05afd434-d7c8-442a-b578-50c054e5cdbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMDT Mini-Rail
Version Model Number1
Catalog NumberM725
Company DUNS054367577
Company NameARROWHEAD DE LLC
Device Count1
DM Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com
Phone901-853-4366
EmailINFO@ArrowheadDevices.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855967006387 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


[00855967006387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-11
Device Publish Date2018-09-10

On-Brand Devices [AMDT Mini-Rail]

00855967006479Bone Screw ø3.0 mm X 100mm long, 40mm thread
00855967006462Bone Screw ø3.0 mm X 100mm long, 30mm thread
00855967006455Bone Screw ø3.0 mm X 80mm long, 25mm thread
00855967006448Threaded Wire, ø2.0mm, 15mm thread, 125mm long
00855967006431Threaded Wire, ø1.6mm, 15mm thread, 125mm long
00855967006424Bone Screw ø3.0 mm X 80mm long, 30mm thread
00855967006417Bone Screw ø3.0 mm X 60mm long, 25mm thread
00855967006400Bone Screw ø3.0 mm X 100mm long, 20mm thread
00855967006394Bone Screw ø3.0 mm X 60mm long, 20mm thread
00855967006387Flexible Rail
00855967006370Rail, 150mm
00855967006363Collet, 3.0mm
00855967006356Collet, 2.0mm
00855967006349Collet, 1.6mm
00855967006332Rail, 100mm
00855967006325Rail, 75mm
00855967006318Rail, 50mm
00855967006301End Clamp, Standard 90°
00855967006295End Clamp, Standard In-line
00855967006288End Clamp, Universal
00855967006271Traveling Clamp, Standard Clutched
00855967006264Traveling Clamp, Universal Clutched

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.