O'NEILL

GUDID 00841543139013

SUNGLASS

Inspecs U.S.A., L.C.

Spectacle frame
Primary Device ID00841543139013
NIH Device Record Keyfe4f0048-ec7e-4614-b609-62a980bea1e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameO'NEILL
Version Model NumberONS-TREVOSE-106P-ST
Company DUNS845937478
Company NameInspecs U.S.A., L.C.
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100841543139013 [Primary]

FDA Product Code

HQYSunglasses (non-prescription including photosensitive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01