1.5 mm Inion OTPS™ PIN-1540

GUDID M224PIN15409

1.5 x 40 mm pin

Inion Oy

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Primary Device IDM224PIN15409
NIH Device Record Key51cec233-e2e8-4f3d-9470-0ba807f433f8
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5 mm Inion OTPS™
Version Model Number1
Catalog NumberPIN-1540
Company DUNS367994657
Company NameInion Oy
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106438408006012 [Secondary]
HIBCCM224PIN15409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2017-02-07

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