OIC Variable Angle Small Fragment Locking Plate System

GUDID 10811998035496

SMALL FRAGMENT MEDIUM DEPTH GAUGE

ORTHOPAEDIC IMPLANT COMPANY, THE

Surgical depth gauge, reusable

• Primary Device ID: 10811998035496
• NIH Device Record Key: d9618075-dd38-4171-81c2-32b2683abf84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OIC Variable Angle Small Fragment Locking Plate System
• Version Model Number: 01-SF19
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811998035496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140357

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

[10811998035496]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-03
• Device Publish Date: 2021-05-26

On-Brand Devices [OIC Variable Angle Small Fragment Locking Plate System]

• M69601SF020: SHARP HOOK
• 10811998033386: SHARP HOOK
• M696LG00280: DRILL GUIDE 2.8MM THREADED
• M696LG00180: DRILL GUIDE 1.8MM THREADED
• M696DG28350: DRILL GUIDE 2.8/3.5MM
• M696DG28280: DRILL GUIDE 2.8MM BONE/PLATE
• M696DG18180: DRILL GUIDE 1.8MM FIX/VARIABLE ANGLE
• 10811998034154: DRILL GUIDE 2.8MM THREADED
• 10811998034147: DRILL GUIDE 1.8MM THREADED
• 10811998033997: DRILL GUIDE 2.8/3.5MM
• 10811998033980: DRILL GUIDE 2.8MM BONE/PLATE
• 10811998033973: DRILL GUIDE 1.8MM FIX/VARIABLE ANGLE
• M69601SF130: SCREW FORCEPS SMALL FRAGMENT
• 10811998033492: SCREW FORCEPS SMALL FRAGMENT
• 10811998035533: 1.6MM X 85MM PROVISIONAL WIRE (5 PACK)
• 10811998039487: SMALL FRAG 2 STERILIZATION CASE
• 10811998035571: 3.5MM X 8MM CORTEX SCREW
• 10811998035564: 3.5MM X 8MM LOCKING SCREW
• 10811998035557: 2.5MM X 8MM CORTEX SCREW
• 10811998035540: 2.5MM X 8MM LOCKING SCREW
• 10811998035526: 2.8MM DRILL TOP HAT
• 10811998035519: 0.8NM TORQUE LIMITER
• 10811998035502: 1.5NM TORQUE LIMITER
• 10811998035496: SMALL FRAGMENT MEDIUM DEPTH GAUGE
• 10811998035489: UNIVERSAL PLATE BENDER
• 10811998035472: THICK TIPPED BONE HOLDERS
• 10811998035465: 2.5MM X 110MM DRILL BIT
• 10811998035458: 1.8/2.5MM DRILL GUIDE
• 10811998035441: 1.8MM DRILL TOP HAT
• 10811998035434: 10 HOLE RIGHT DISTAL CLAVICLE PLATE
• 10811998035427: 10 HOLE LEFT DISTAL CLAVICLE PLATE
• 10811998035410: 8 HOLE RIGHT DISTAL CLAVICLE PLATE
• 10811998035403: 8 HOLE LEFT DISTAL CLAVICLE PLATE
• M696DR0010: STERILIZATION CASE DRILL BIT CADDY
• M69601SF000: STERILIZATION CASE VA SMALL FRAG BASE
• M69601PRXTIB010: STERILIZATION CASE PROX TIB PLATES
• M69601PHP040: STERILIZATION CASE PROXIMAL PLATE COMPLETE
• M69601PHP030: STERILIZATION CASE PROXIMAL HUMERUS PLATES INNER
• M69601FIB010: STERILIZATION CASE FIBULA PLATES
• M69601DRP040: STERILIZATION CASE DISTAL RADIUS PLATES COMPLETE
• M69601DRP030: STERILIZATION CASE DISTAL RADIUS PLATES INNER
• M69601CP020: STERILIZATION CASE CLAVICLE PLATES COMPLETE
• M69601CP010: STERILIZATION CASE CLAVICLE PLATES INNER
• M69601ANK010: STERILIZATION CASE ANKLE PLATES
• M696014150: STERILIZATION CASE UNIVERSAL OUTER MINI
• 10811998033362: STERILIZATION CASE VA SMALL FRAG BASE
• 10811998033355: STERILIZATION CASE PROX TIB PLATES
• 10811998033348: STERILIZATION CASE PROXIMAL PLATE COMPLETE
• 10811998033317: STERILIZATION CASE DISTAL RADIUS PLATES COMPLETE
• 10811998033263: STERILIZATION CASE CLAVICLE PLATES COMPLETE