Polyaxial Silicone Handle

GUDID 00854515008842

Unique Surgical

Surgical instrument handle, non-torque-limiting
Primary Device ID00854515008842
NIH Device Record Keyfeb105e8-2226-4053-91ae-a65ec337bade
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolyaxial Silicone Handle
Version Model NumberRatcheting
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854515008842 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

[00854515008842]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-15
Device Publish Date2025-08-07

Devices Manufactured by Unique Surgical

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00854515008675 - Cerclage Passer2025-08-15
00854515008682 - Cerclage Passer2025-08-15
00854515008699 - Resection Guide2025-08-15
00854515008705 - Resection Guide2025-08-15
00854515008712 - Drill Bit Driver2025-08-15
00854515008729 - Holding Pin2025-08-15
00854515008736 - Pin Driver2025-08-15
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