TSI

GUDID 00843059112351

LED LIGHT SOURCE

TEDAN SURGICAL INNOVATIONS, L.L.C.

General-purpose light source

• Primary Device ID: 00843059112351
• NIH Device Record Key: 7fb02105-f241-4113-8d99-0e6963ad188b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI
• Version Model Number: ML-0051
• Company DUNS: 791619393
• Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843059112351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093792

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-22

On-Brand Devices [TSI]

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