Angled Driver 1040.00.039

GUDID 00854515008309

Unique Surgical

Drilling power tool attachment, basic
Primary Device ID00854515008309
NIH Device Record Keyc4faa553-a960-4350-a3f9-60690f58892d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngled Driver
Version Model Number45 Degree
Catalog Number1040.00.039
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854515008309 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854515008309]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-13
Device Publish Date2023-01-05

Devices Manufactured by Unique Surgical

00854515008385 - Tibial Cutting Jig2023-06-30
00854515008323 - Patella Clamp2023-05-03
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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