Universal Dilator 521-0002

GUDID M7405210002

Pedicle Markers

SPINEOLOGY INC.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDM7405210002
NIH Device Record Key00b38aea-cfa4-419d-8d45-a8ab706440ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Dilator
Version Model Number52-02-09
Catalog Number521-0002
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405210002 [Primary]

FDA Product Code

LXNProbe, Test, Heart-Valve

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


[M7405210002]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-27
Device Publish Date2023-12-19

On-Brand Devices [Universal Dilator ]

M7401001271Snap Lock Ring
M7401001270Impact Cap Snap Lock
M7405230012Wrench
M7405230004Tightener
M7405230003Snap Clip
M7405230002Impact Cap
M7405230001Cannulated Dilator
M7405210005Non-Threaded, Double Ring
M7405210004Pedicle Markers
M7405210003Non- threaded, Single Ring
M7405210002Pedicle Markers
M7405210001Pedicle Marker Inserter

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