OIC Intramedullary Nail System

GUDID 10811998036028

T-HANDLE AWL

ORTHOPAEDIC IMPLANT COMPANY, THE

Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable

• Primary Device ID: 10811998036028
• NIH Device Record Key: e5e4013a-9f31-4025-aa9a-d5ad70246af5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OIC Intramedullary Nail System
• Version Model Number: 01-IM01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811998036028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150655

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[10811998036028]

Moist Heat or Steam Sterilization

[10811998036028]

Moist Heat or Steam Sterilization

[10811998036028]

Moist Heat or Steam Sterilization

[10811998036028]

Moist Heat or Steam Sterilization

[10811998036028]

Moist Heat or Steam Sterilization

[10811998036028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-07-31

On-Brand Devices [OIC Intramedullary Nail System]

• M69601IM480: EXTRACTION BOLT
• 10811998036554: EXTRACTION BOLT, FEMUR
• 10811998036462: EXTRACTION BOLT
• 10811998038084: BALL TIP GUIDE ROD 3.0MM X 800MM (PACK OF 10)
• 10811998038138: 127.5 DEGREE HIP NAIL 10MM X 180MM
• 10811998038121: SET SCREW EXTRACTION TOOL, 4.5MM HEX
• 10811998038114: 4.0MM X 155MM RADIOLUCENT TWIST DRILL BIT
• 10811998038107: 127.5 DEGREE HIP NAIL 11MM X 440MM RIGHT
• 10811998038091: 127.5 DEGREE HIP NAIL 11MM X 440MM LEFT
• M69601TIB010: STERILIZATION CASE IM NAIL TIBIA TRAY
• M69601IM550: STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
• M69601IM540: STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
• M69601IM000: STERILIZATION CASE IM NAIL BASE TRAY
• M69601ARFN0010: STERILIZATION CASE IM NAIL ARFN TRAY
• 10811998036585: STERILIZATION CASE IM TIBIA NAILS
• 10811998036578: STERILIZATION CASE IM NAIL EXTRACTION SET TRAY
• 10811998036530: STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
• 10811998036523: STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
• 10811998036011: STERILIZATION CASE IM NAIL BASE TRAY
• 10811998036004: STERILIZATION CASE IM NAIL ARFN TRAY
• 10811998038145: 127.5 DEGREE HIP NAIL 10MM X 210MM
• M69601IM520: IM NAIL REDUCTION TOOL
• M69601IM010: T-HANDLE AWL
• 10811998036509: IM NAIL REDUCTION TOOL
• 10811998036028: T-HANDLE AWL
• 10811998038169: 10 mm x 600 mm FUSION NAIL, RIGHT
• 10811998038152: 10 mm x 600 mm FUSION NAIL, LEFT
• M696GW031000S0: BALL TIP GUIDE ROD 3.0MM X 1000MM
• 10811998036851: BALL TIP GUIDE ROD 3.0MM X 1000MM
• 10811998036844: BALL TIP GUIDE ROD 3.0MM X 1000MM