Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

GUDID M678DPLS400W0

Xenon Lightsource, 400 Watt, Digital

SUNOPTIC TECHNOLOGIES LLC

General-purpose light source
Primary Device IDM678DPLS400W0
NIH Device Record Keyb9a9c21d-5e0a-41ce-95cd-951de59014ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
Version Model NumberDPLS-02, DPLS-04
Company DUNS094586898
Company NameSUNOPTIC TECHNOLOGIES LLC
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 Numbertrue
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
HIBCCM678DPLS400W0 [Primary]

FDA Product Code

FSSLight, Surgical, Floor Standing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-09
Device Publish Date2023-03-01

On-Brand Devices [Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer]

M678DPLS300W0Xenon Lightsource, 300 Watt, Digital
M678SLSS0Battery powered light source for illumination of a surgical field.
M678DPLS400W0Xenon Lightsource, 400 Watt, Digital

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