ABN Deluxe Penlight

GUDID 08997021263526

ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mouth.

SUGIH INSTRUMENDO ABADI, PT

Hand-held examination/treatment light
Primary Device ID08997021263526
NIH Device Record Key61db539a-6d9d-42b9-895f-5bae19f38f93
Commercial Distribution StatusIn Commercial Distribution
Brand NameABN Deluxe Penlight
Version Model NumberPL-900-212
Company DUNS726548899
Company NameSUGIH INSTRUMENDO ABADI, PT
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108997021263526 [Primary]

FDA Product Code

KYTLight, Examination, Medical, Battery Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

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08997021263526 - ABN Deluxe Penlight2023-06-19ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mouth.
08997021263526 - ABN Deluxe Penlight2023-06-19 ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mou

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