Inion OTPS Pin Instruments INS-9246

GUDID M224INS92469

Percutaneous drill 2.0 mm

Inion Oy

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable
Primary Device IDM224INS92469
NIH Device Record Key5ca62abb-916b-446c-b236-fa5d76b70ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameInion OTPS Pin Instruments
Version Model Number1
Catalog NumberINS-9246
Company DUNS367994657
Company NameInion Oy
Device Count1
DM Exempttrue
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
GS106438408004742 [Primary]
HIBCCM224INS92469 [Secondary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M224INS92469]

Moist Heat or Steam Sterilization


[M224INS92469]

Moist Heat or Steam Sterilization


[M224INS92469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-18
Device Publish Date2020-05-08

On-Brand Devices [Inion OTPS Pin Instruments]

M224INS92469Percutaneous drill 2.0 mm
06438408004735Percutaneous piston 2.0mm
M224INS92319Pin applicator 2.0 mm
M224INS92309Pin applicator 1.5 mm
M224ACC98209Sterilization tray
06438408004728Percutaneous tip 2.0 mm
M224INS92349Arthroscopic tip 2.0 mm

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