OTIS-F EVO90T3741

GUDID 03760154008167

Handle for the OTIS-F AO drill guide

S.B.M

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID03760154008167
NIH Device Record Key8a4e7987-cec0-44a3-a823-6b2e3da3eeaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTIS-F
Version Model NumberHandle for OTIS-F AO tap
Catalog NumberEVO90T3741
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
GS103760154008167 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


[03760154008167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

On-Brand Devices [OTIS-F]

03760154009485OTIS-F cleaning and sterilization basket.
03760154009492Complete instrumentation tray composed of reusable surgical instruments intended to be used for
03760154008181AO Ø 6.5 mm tap
03760154008174AO drill guide
03760154008167Handle for the OTIS-F AO drill guide

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