Alignment Guide

GUDID 00854515008361

Unique Surgical

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Primary Device ID00854515008361
NIH Device Record Key11a22dbb-aa9e-40fe-9a84-9dd1cd42b575
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignment Guide
Version Model NumberTibial, Intramedullary (IM)
Company DUNS079820535
Company NameUnique Surgical
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com
Phone818-813-8527
Emailinfo@UniqueSurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854515008361 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

[00854515008361]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2023-01-06

Devices Manufactured by Unique Surgical

00854515008385 - Tibial Cutting Jig2023-06-30
00854515008323 - Patella Clamp2023-05-03
00854515008361 - Alignment Guide2023-05-03
00854515008361 - Alignment Guide2023-05-03
00854515008101 - Lima Femoral Cutting Block2023-01-13
00854515008132 - Lima Femoral Cutting Block2023-01-13
00854515008149 - IM Rod2023-01-13
00854515008156 - T-Handle2023-01-13
00854515008231 - Angled Drill Bit2023-01-13
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