Fiber Optic Illuminator

GUDID 00869836000345

I-TEK MEDICAL SOLUTIONS, INC.

Surgical instrument fibreoptic light
Primary Device ID00869836000345
NIH Device Record Keyb6b9da91-9f90-4ca2-8752-b32fb2baaa80
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiber Optic Illuminator
Version Model Number1090-001
Company DUNS080599644
Company NameI-TEK MEDICAL SOLUTIONS, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-454-6602
Emailinfo@i-tekmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100869836000345 [Primary]
GS110869836000342 [Package]
Package: Case [1 Units]
In Commercial Distribution

FDA Product Code

FDGRetractor, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-05
Device Publish Date2019-05-28

On-Brand Devices [Fiber Optic Illuminator]

108698360003111136-001
008698360003451090-001
108698360003281102-001

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