ORTHO SOLUTIONS STERILE DRILL BITS OSH-9228

GUDID 05055662943788

BURR ROUND CARBIDE 4MM X 73MM

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bur, single-use

• Primary Device ID: 05055662943788
• NIH Device Record Key: 941b56c7-4c7d-4bd1-bf6b-90841238a6c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS STERILE DRILL BITS
• Version Model Number: OSH-9228
• Catalog Number: OSH-9228
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662943788 [Package]; Contains: 05055662943795; Package: Cardboard Box [5 Units]; In Commercial Distribution
GS1	05055662943795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102743

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-24

On-Brand Devices [ORTHO SOLUTIONS STERILE DRILL BITS]

• 05055662944525: J-LATCH BURR SS 4.5MM X 55MM
• 05055662944464: J-LATCH BURR OVAL CARBIDE 4.0MM X 55MM
• 05055662943801: BURR ROUND CARBIDE 5MM X 70MM
• 05055662943788: BURR ROUND CARBIDE 4MM X 73MM
• 05055662943764: BURR ROUND CARBIDE 3MM X 73MM
• 05055662943542: BURR ROUND CARBIDE 4MM X 51MM
• 05055662942620: SAGITTAL BLADE 100.0MM X 20.0MM X 1.27MM
• 05055662942606: SAGITTAL BLADE 80.0MM X 29.0MM X 1.27MM
• 05055662942583: SAGITTAL BLADE 83.5MM X 18.5MM X 1.27MM
• 05055662942545: SAGITTAL BLADE 80.0MM X 25.0MM X 1.50MM
• 05055662942507: SAGITTAL BLADE 73.8MM X 25.0MM X 0.89MM
• 05055662942484: SAGITTAL BLADE 80.0MM X 12.5MM X 1.27MM
• 05055662942460: SAGITTAL BLADE 73.0MM X 12.5MM X 1.27MM
• 05055662942446: SAGITTAL BLADE 82.2MM X 12.5MM X 1.19MM
• 05055662942422: SAGITTAL BLADE 85.0MM X 25.0MM X 1.20MM
• 05055662942309: SAGITTAL BLADE 55.0MM X 27.0MM X 0.64MM
• 05055662942286: SAGITTAL BLADE 90.0MM X 19.05MM X 1.27MM
• 05055662942187: SAGITTAL BLADE 60.0MM X 19.0MM X 0.64MM
• 05055662942149: SAGITTAL BLADE 99.3MM X 25.0MM X 1.27MM
• 05055662942040: SAGITTAL BLADE 85.0MM X 20.5MM X 0.89MM
• 05055662942026: SAGITTAL BLADE 70.0MM X 25.0MM X 0.89MM
• 05055662942002: SAGITTAL BLADE 89.5MM X 12.5MM X 0.89MM
• 05055662941982: SAGITTAL BLADE 85.0MM X 25.0MM X 0.89MM
• 05055662941968: SAGITTAL BLADE 75.0MM X 25.0MM X 0.64MM
• 05055662941920: RECIPROCATING BLADE 78.0MM X 11.2MM X 0.64MM
• 05055662941883: RECIPROCATING BLADE 70.0MM X 12.7MM X 0.64MM
• 05055662941821: SAGITTAL BLADE 90.0MM X 25.0MM X 1.35MM
• 05055662941807: SAGITTAL BLADE 100.0MM X 25.0MM X 1.27MM
• 05055662941784: SAGITTAL BLADE 90.0MM X 25.0MM X 1.27MM
• 05055662941722: OSCILLATING BLADE 25.0MM X 5.5MM X 0.38MM
• 05055662941661: OSCILLATING BLADE 10.0MM X 5.5MM X 0.38MM
• 05055662941609: OSCILLATING BLADE 15.0MM X 5.5MM X 0.51MM
• 05055662941548: OSCILLATING BLADE 30.0MM X 9.0MM X 0.51MM
• 05055662941487: OSCILLATING BLADE 30.0MM X 9.0MM X 0.51MM
• 05055662941463: OSCILLATING BLADE 25.0MM X 7.0MM X 0.51MM
• 05055662941449: OSCILLATING BLADE 15.0MM X 7.0MM X 0.51MM
• 05055662941425: OSCILLATING BLADE 25.0MM X 9.0MM X 0.51MM
• 05055662941388: OSCILLATING BLADE 15.0MM X 9.0MM X 0.51MM
• 05055662941302: OSCILLATING BLADE 30.0MM X 9.0MM X 0.38MM
• 05055662941289: OSCILLATING BLADE 15.0MM X 5.5MM X 0.38MM
• 05055662941265: OSCILLATING BLADE 30.0MM X 9.0MM X 0.38MM
• 05055662941241: OSCILLATING BLADE 25.0MM X 7.0MM X 0.38MM
• 05055662941227: OSCILLATING BLADE 15.0MM X 7.0MM X 0.38MM
• 05055662941203: OSCILLATING BLADE 25.0MM X 9.0MM X 0.38MM
• 05055662941180: OSCILLATING BLADE 35.0MM X 12.5MM X 0.38MM
• 05055662941142: OSCILLATING BLADE 15.0MM X 9.0MM X 0.38MM
• 05055662941005: SAGITTAL BLADE 95.0MM X 25.0MM X 1.27MM
• 05055662940961: SAGITTAL BLADE 90.0MM X 25.4MM X 1.27MM
• 05055662940725: OSCILLATING BLADE 27.0MM X 10.0MM
• 05055662939484: SAGITTAL BLADE 63.0MM X 19.5MM X 0.6MM