OTIS-C-PLUS & OTIS-F EVO9069430

GUDID 03760154008112

Drill guide for use with OTIS-C-PLUS and OTIS-F osteosynthesis plates for HTO.

S.B.M

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID03760154008112
NIH Device Record Keyf0e4d599-b76a-42f9-9f62-8aa9113bbb4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTIS-C-PLUS & OTIS-F
Version Model NumberDrill guide
Catalog NumberEVO9069430
Company DUNS772462123
Company NameS.B.M
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154008112 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


[03760154008112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

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03760154003513 - FIXIT2024-06-20 Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the
03760154003520 - FIXIT2024-06-20 Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the
03760154003919 - LIGAFIX2024-06-20 Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the
03760154003995 - LIGAFIX2024-06-20 Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the
03760154006194 - GraftTech2024-06-20 Complete graft preparation station set intended to be used to prepare the graft + PULLUP construct for arthroscopic reconstructi
03760154008143 - OTIS2024-06-20 Complete instrumentation set composed of reusable surgical instruments intended to be used for high tibial osteotomy.

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