Piranha

GUDID 00840916112578

Piranha Cervical Screw Ø 4.0mm x 18mm

SPINAL ELEMENTS

Cervical total disc replacement prosthesis, non-sterile

• Primary Device ID: 00840916112578
• NIH Device Record Key: 37049ee1-73ab-4ddd-b3ea-043297015d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piranha
• Version Model Number: CSF-40-18
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916112578 [Primary]

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

[00840916112578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-25
• Device Publish Date: 2017-07-11

On-Brand Devices [Piranha]

• 00840916112752: Piranha, Rescue Variable Screw Ø 4.25mmx14mm
• 00840916112745: Piranha, Rescue Variable Screw Ø 4.25mm x 12mm
• 00840916112738: Piranha, Self Drilling Variable Screw Ø 4.0mmx18mm
• 00840916112721: Piranha, Self Drilling Variable Screw Ø 4.0mmx16mm
• 00840916112714: Piranha, Self Drilling Variable Screw Ø 4.0mmx14mm
• 00840916112707: Piranha, Self Drilling Variable Screw Ø 4.0mmx12mm
• 00840916112691: Piranha Cervical Screw Ø 4.25mm x 12mm
• 00840916112684: Piranha Cervical Variable Screw Ø 4.25mm x 16mm
• 00840916112677: Piranha Cervical Variable Screw Ø 4.25mm x 14mm
• 00840916112660: Piranha Cervical Variable Screw Ø 4.25mm x 12mm
• 00840916112653: Piranha Cervical Variable Screw Ø 4.0mm x 18mm
• 00840916112646: Piranha Cervical Variable Screw Ø 4.0mm x 16mm
• 00840916112639: Piranha Cervical Variable Screw Ø 4.0mm x 14mm
• 00840916112622: Piranha Variable Screw Ø 4.0mm x 12mm
• 00840916112615: Piranha Cervical Screw Ø 4.25mm x 18mm
• 00840916112608: Piranha Cervical Screw Ø 4.25mm x 16mm
• 00840916112592: Piranha Cervical Screw Ø 4.25mm x 14mm
• 00840916112585: Piranha Cervical Screw Ø 4.25mm x 12mm
• 00840916112578: Piranha Cervical Screw Ø 4.0mm x 18mm
• 00840916112561: Piranha Cervical Screw Ø 4.0mm x 16mm
• 00840916112554: Piranha Cervical Screw Ø 4.0mm x 14mm
• 00840916112547: Piranha Cervical Screw Ø 4.0mm x 12mm
• 00840916156695: QC PIRANHA DRIVER
• 00840916156602: PIRANHA STAB AND GRAB DRIVER
• 00840916156596: PIRANHA SWIVEL-TOP SCREWDRIVER
• 00840916156589: PIRANHA EXTRA LONG AO DRIVER
• 00840916156572: PIRANHA SCREW CADDY
• 00840916156558: PIRANHA TEMPORARY FIXATION PIN INSERTER
• 00840916156527: 9MM AWLS
• 00840916156466: VARIABLE CERVICAL DRILL GUIDE
• 00840916156459: PIRANHA SCREW CADDY
• 00840916156442: PIRANHA SET 4 LEVEL CADDY
• 00840916156435: PIRANHA SET 3 LEVEL CADDY
• 00840916156428: PIRANHA SET 2 LEVEL CADDY
• 00840916156411: PIRANHA SET 1 LEVEL CADDY
• 00840916156404: DOUBLE BARREL DRILL GUIDE
• 00840916156299: 10 MM DRILL BITSHAFT
• 00840916156282: 10 MM DRILL BIT
• 00840916150983: CERVICAL PLATE HEX DRIVER
• 00840916143152: CERVICAL PLATE HOLDER
• 00840916143138: CERVICAL PLATE BENDER
• 00840916143091: Piranha, Rescue Variable Screw Ø 4.25mmx18mm
• 00840916143084: Piranha, Rescue Variable Screw Ø 4.25mmx16mm
• 00840916143220: Piranha Solid Drill Guide
• 00840916143213: Piranha Screw Caddy Platform
• 00840916143206: Bone Awl
• 00840916143190: Plate Shield Driver
• 00840916143183: Cervical Marker Screw
• 00840916143176: Piranha Hex Driver Stab & Grab Tip
• 00840916143169: Cervical Mini-Ratchet Handle (G130150)