S4 OPTIK 100258A50.J V0

GUDID 08056098470234

SLIT LAMP SL9800 5X

COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

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Primary Device ID08056098470234
NIH Device Record Keycf57afe8-3d4b-4e07-bb08-983e2d21fc11
Commercial Distribution StatusIn Commercial Distribution
Brand NameS4 OPTIK
Version Model NumberSL 9800 5X LED
Catalog Number100258A50.J V0
Company DUNS432448470
Company NameCOSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056098470234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJOBiomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-18
Device Publish Date2020-12-10

On-Brand Devices [S4 OPTIK]

08056098471606SLIT LAMP SL9800 5X
08056098471590SLIT LAMP SL9800 3X
08056098470852SLIT LAMP SL9900 ELITE
08056098470838SLIT LAMP SL9900 5X
08056098470821SLIT LAMP SL9900 5X
08056098470814SLIT LAMP SL9900 3X digital
08056098470807SLIT LAMP SL9900 3X
08056098470791SLIT LAMP SL9900 2X
08056098470784SLIT LAMP SL9900 ZOOM
08056098470777SLIT LAMP SL9800 5X
08056098470760SLIT LAMP SL9800 3X
08056098470753SLIT LAMP SL9800 2X
08056098470708SLIT LAMP SL990 2X
08056098470678SLIT LAMP SL9800 zoom
08056098470234SLIT LAMP SL9800 5X
08056098470197SLIT LAMP SL9800 2X
08056098470166SLIT LAMP SL990 5X
08056098470159SLIT LAMP SL990 5X DIGITAL
08056098470517APPLANATION TONOMETER
08056098470425APPLANATION TONOMETER
08056098470647SLIT LAMP SL990 5X YELLOW FILTER+REHOSTAT
08056098470258SLIT LAMP SL990 ELITE
08056098470227SLIT LAMP SL9800 3X DIGITAL
08056098470210SLIT LAMP SL9900 3X DIGITAL
08056098470135SLIT LAMP SL9900 3X YELLOW FILTER+REHOSTAT
08056098470128SLIT LAMP SL9900 3X DIGITAL
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