OTIS-C-PLUS EVO9069432

GUDID 03760154001038

Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO.

S.B.M

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Primary Device ID03760154001038
NIH Device Record Keycfd3208c-ef41-46e8-bd56-1558f873ecf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTIS-C-PLUS
Version Model NumberDrill bit
Catalog NumberEVO9069432
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 Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter
Outer Diameter3.5 Millimeter
Length195 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154001038 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


[03760154001038]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-27
Device Publish Date2023-12-19

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

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