TSI

GUDID 00843059112351

LED LIGHT SOURCE

TEDAN SURGICAL INNOVATIONS, L.L.C.

General-purpose light source
Primary Device ID00843059112351
NIH Device Record Key7fb02105-f241-4113-8d99-0e6963ad188b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI
Version Model NumberML-0051
Company DUNS791619393
Company NameTEDAN SURGICAL INNOVATIONS, L.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 Batchtrue
Serial Numberfalse
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
GS100843059112351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCWLight Source, Fiberoptic, Routine

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


[00843059112351]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-22

On-Brand Devices [TSI]

00851797006993U-BAR, FRONT
00851797006986U-BAR, SIDE
00851797006979VERTICAL POST, FRONT
00851797006962VERTICAL POST, REAR
00851797006955DUAL STARBURST TABLE CLAMP
00851797006948SKULL CLAMP DUAL FLEX ARM HOLDER
00851797006931SINGLE FLEX ARM HOLDER
00851797006924UNIVERSAL SPATULA HOLDER
00851797006917SPATULA HOLDER
00851797006900PATTIE TRAY
00851797006894NEURO FLEX ARM, 16.5CM (6.5")
00851797006887NEURO FLEX ARM, 42CM (16.5")
00851797006870NEURO FLEX ARM, 38CM (14.5")
00851797006863LIGHT CABLE, STANDARD CURVE, 10'
00851797006856FLEX ARM LIGHT CABLE HOLDER, LARGE
00851797006849STERILIZATION TRAY, ML-2009
00851797006832ANGLED ARTICULATING ARM, RACK CLAMP
00851797006825ROTATABLE TABLE CLAMP
00851797006818CONCAVE SPATULA, 75 MM, 20 MM, SST
00851797006801CONCAVE SPATULA, 75 MM, 16 MM, SST
00851797006795CONCAVE SPATULA, 75 MM, 13 MM, SST
00851797006788CONCAVE SPATULA, 75 MM, 10 MM, SST
00851797006771CONCAVE SPATULA, 75 MM, 8 MM, SST
00851797006764CONCAVE SPATULA, 75 MM, 5 MM, SST
00851797006757CONCAVE SPATULA, 65 MM, 20 MM, SST
00851797006740CONCAVE SPATULA, 65 MM, 16 MM, SST
00851797006733CONCAVE SPATULA, 65 MM, 13 MM, SST
00851797006726CONCAVE SPATULA, 65 MM, 10 MM, SST
00851797006719CONCAVE SPATULA, 65 MM, 8 MM, SST
00851797006702CONCAVE SPATULA, 65 MM, 5 MM, SST
00851797006696CONCAVE SPATULA, 45 MM, 20 MM, SST
00851797006689CONCAVE SPATULA, 45 MM, 16 MM, SST
00851797006672CONCAVE SPATULA, 45 MM, 13 MM, SST
00851797006665CONCAVE SPATULA, 45 MM, 10 MM, SST
00851797006658CONCAVE SPATULA, 45 MM, 8 MM, SST
00851797006641CONCAVE SPATULA, 45 MM, 5 MM, SST
00851797006634DAVIS STYLE SPATULA, 38 MM, SST
00851797006627DAVIS STYLE SPATULA, 38 MM, SST
00851797006610DAVIS STYLE SPATULA, 32 MM, SST
00851797006603DAVIS STYLE SPATULA, 25 MM, SST
00851797006597DAVIS STYLE SPATULA, 19 MM, SST
00851797006580DAVIS STYLE SPATULA, 16 MM, SST
00851797006573DAVIS STYLE SPATULA, 13 MM, SST
00851797006566DAVIS STYLE SPATULA, 10 MM, SST
00851797006559DAVIS STYLE SPATULA, 6 MM, SST
00851797006542MALLEABLE TAPERED SPATULA, 200 MM, 7.0 MM, SST
00851797006535MALLEABLE TAPERED SPATULA, 200 MM, 5.8 MM, SST
00851797006528MALLEABLE TAPERED SPATULA, 200 MM, 3.8 MM, SST
00851797006511MALLEABLE TAPERED BRAIN SPATULA 200 MM, 2.2 MM, SST
10851797006501LIGHT CABLE, 10', STERILE, 5/BOX

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