Drive Rail 21-2011

GUDID 00817867020443

Drive Shaft

DEVISE ORTHO INC.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use
Primary Device ID00817867020443
NIH Device Record Key452d8c86-4050-45a9-8369-78aad9568983
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrive Rail
Version Model Number21-2011
Catalog Number21-2011
Company DUNS080456972
Company NameDEVISE ORTHO INC.
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 Batchfalse
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

Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com
Phone901-748-2581
Emailinfo@deviseortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817867020443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

[00817867020443]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-13

On-Brand Devices [Drive Rail]

00817867020481Rotating Carriage Locking Disk
00817867020474Rotating Carriage
00817867020450Clamp, Angle 2 Hole
00817867020443Drive Shaft
00817867020436Carriage, Rail Arch
00817867020429Standard Carriage
00817867020412Add-A-Rail, 100mm
00817867020405Add-A-Rail, 50mm
00817867020399Rail, 200mm
00817867020382Rail, 100mm
00817867020375Screw, 1/4-28 X 45mm
00817867020368Screw, 1/4-28 X 29mm
00817867020351Screw, 1/4-20 X 22mm
00817867020344Screw, 1/4-28 X 13mm
00817867020337Set Screw
00817867020320Screw, Clamp To Carriage
00817867020313Screw, Short, Clamp To Carriage
00817867020306Hinge, Low Overhang +5mm
00817867020290Hinge, High Overhang
00817867020283Hinge, Low Overhang
00817867020276Hinge, High Range
00817867020269Hinge, Low Range
00817867020252Post, 6 Hole
00817867020245Post, 5 Hole
00817867020238Post, 4 Hole
00817867020221Post, 3 Hole
00817867020214Post, 2 Hole
00817867020207Post, 1 Hole
00817867020191Clamp, 7 Hole Stacked (5, 2 Config)
00817867020184Clamp, 5 Hole In-Line
00817867020177Clamp, 5 Hole Stacked (4, 1 Config)
00817867020160Clamp, 4 Hole In-Line
00817867020153Clamp, 3 Hole In-Line
00817867020146Clamp, 2 Hole In-Line
00817867020139Clamp, 1 Hole
00817867020122Drive Mechanism
00817867020115Rail End Cap
00817867020108Arch, 41 cm
00817867020092Arch, 34 cm
00817867020085Arch, 27 cm
00817867020078Arch, 20 cm
00817867020061Arch, 13 cm
00817867020054Arch, 9 cm
00817867020047Rail Hinge Mount/Rail Stop
00817867020030Clamp Rotational Mount
00817867020023Rail Rotational Mount
00817867020016Arch Rotational Mount
00817867020511Hinge, 0 to 7.5mm
00817867020504Hinge, 12.5 to 20mm
00817867020498Rotating Carriage Free Disk
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