Osteotec CBG Spike L OST-CBG-17

GUDID 05060183095717

A spike has been included in the kit, this is to be inserted through the body of the tube saw and is used to centralize the saw when starting the cut.

OSTEOTEC LIMITED

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Primary Device ID05060183095717
NIH Device Record Key5fb70cf2-2a8c-4e5f-8a65-95b014945aff
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotec CBG Spike L
Version Model NumberOST-CBG-17
Catalog NumberOST-CBG-17
Company DUNS348489386
Company NameOSTEOTEC LIMITED
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
GS105060183095717 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


[05060183095717]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-14
Device Publish Date2022-02-04

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