OTIS-C-PLUS EVO90FA800

GUDID 03760154008150

Complete instrumentation set composed of reusable surgical instruments intended to be used for high tibial osteotomy.

S.B.M

General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable General surgical procedure kit, non-medicated, reusable
Primary Device ID03760154008150
NIH Device Record Key618e4e28-5884-4100-9055-9dd7fd43b94c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTIS-C-PLUS
Version Model NumberOTIS-C-PLUS complete instrumentation set
Catalog NumberEVO90FA800
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 Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS103760154008150 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


[03760154008150]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-20
Device Publish Date2024-06-12

On-Brand Devices [OTIS-C-PLUS]

03760154001052Screwdriver for use with OTIS-C-PLUS osteosynthesis plates and associated OTIS screws for HTO.
03760154001045Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.
03760154001038Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.
03760154001014Drill guide for use with OTIS-C-PLUS osteosynthesis plates for HTO.
03760154006279OTIS-C-PLUS cleaning and sterilization basket.
03760154006248OTIS-C-PLUS® countersink bit
03760154006224OTIS-C-PLUS Ø 3 mm drill bit for temporary screw
03760154008150Complete instrumentation set composed of reusable surgical instruments intended to be used for h

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