LEOS Cannulated Screw System 76308832

GUDID 00810040689789

1.1 X 152mm K-wire double end trocar tip

Tyber Medical LLC

Orthopaedic guidewire, single-use

• Primary Device ID: 00810040689789
• NIH Device Record Key: adab6859-b47c-414d-84c4-22445988754c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEOS Cannulated Screw System
• Version Model Number: 76308832
• Catalog Number: 76308832
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com
• Phone: +1(866)761-0933
• Email: preese@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810040689789 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [LEOS Cannulated Screw System]

• 00810040689994: LEOS Cannulated 3.5/4.0 Screws Aux Case
• 00810040689987: Lid 2.0/2.5/3.0/3.5/4.0 HD Screws
• 00810040689970: Lid 2.0/2.5/3.0/3.5/4.0 HLESS Screws
• 00810040689963: Caddy 2.0/2.5/3.0/3.5/4.0 HD Screws
• 00810040689956: Caddy 2.0/2.5/3.0/3.5/4.0 HLESS Screws
• 00810040689949: Instrument Tray 2.0/2.5/3.0/3.5/4.0
• 00810040689925: LEOS Cannulated Small Screw System Case
• 00810040689918: 7.0mm Washer
• 00810040689901: 7.0 X 229mm Overdrill Large AO
• 00810040689895: 5.0 X 229mm Drill Large AO
• 00810040689888: 2.8 X 229mm K-wire fluted tip
• 00810040689871: 5.5mm Washer
• 00810040689864: 5.5 X 229mm Overdrill Large AO
• 00810040689857: 3.0 X 229mm Drill Large AO
• 00810040689840: 1.6 X 229mm K-wire
• 00810040689833: 4.0mm Washer
• 00810040689826: 2.7 X 152mm Drill AO
• 00810040689819: 1.4 X 152mm K-wire
• 00810040689796: 2.0 X 152mm Drill AO
• 00810040689789: 1.1 X 152mm K-wire double end trocar tip
• 00810040689772: 1.1 X 152mm K-wire single end trocar tip
• 00810040689765: 1.6 X 152mm Drill AO
• 00810040689758: 0.9 X 152mm K-wire double end trocar tip
• 00810040689741: 0.9 X 152mm K-wire single end trocar tip
• 00810040689734: Tissue Protector Outer Sleeve 3.5/4.0
• 00810040689727: Parallel Wire Guide 7.0 Cann Screws
• 00810040689710: 7.0mm Tap
• 00810040689703: Cleaning Stylet 7.0 Screws
• 00810040689697: Countersink 7.0 Cann HD Screws
• 00810040689680: Countersink 7.0 Cann HLESS Screws
• 00810040689666: T30 Driver Large AO
• 00810040689659: Wire Insert 7.0 Cann Screws
• 00810040689611: Tissue Protector Outer Sleeve 7.0
• 00810040689598: T Handle Large AO
• 00810040689581: Ratcheting Handle Axial Large AO
• 00810040689574: 229mm Depth Gauge
• 00810040689567: Tissue Protector Outer Sleeve 5.5
• 00810040689550: Parallel Wire Guide 4.0/5.5 Cann Screws
• 00810040689543: 5.5mm Tap
• 00810040689536: Countersink 5.5 Cann HD Screws
• 00810040689529: Countersink 5.5 Cann HLESS Screws
• 00810040689512: Wire Insert 5.5 Cann Screws
• 00810040689505: T15 Driver Large AO
• 00810040689482: Cleaning Stylet 5.5 Screws
• 00810040689475: Countersink 3.5/4.0 Cann HD Screws
• 00810040689468: Wire Insert 3.5/4.0 LEOS Drill Guide
• 00810040689451: Wire Insert 4.0 Cann Screws
• 00810040689444: T15 Driver AO
• 00810040689437: Dispenser 1.1mm K-wire-double tip
• 00810040689420: Dispenser 1.1mm K-wire-single tip