Sonoma Orthopedic Products, Inc. CS6135-S

GUDID 00816988012443

SONOMA ORTHOPEDIC PRODUCTS, INC.

Fluted surgical drill bit, single-use, sterile

• Primary Device ID: 00816988012443
• NIH Device Record Key: c185311c-0b15-47ce-a02e-1952902a8de4
• Commercial Distribution Discontinuation: 2016-02-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sonoma Orthopedic Products, Inc.
• Version Model Number: 3.5mm Solid Drill, Sterile
• Catalog Number: CS6135-S
• Company DUNS: 884789251
• Company Name: SONOMA ORTHOPEDIC PRODUCTS, INC.
• 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: false
• Expiration Date: true
• 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	00816988012443 [Primary]

FDA Product Code

• HTW: Bit, Drill

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: 2018-11-22
• Device Publish Date: 2016-01-28

On-Brand Devices [Sonoma Orthopedic Products, Inc.]

• 00081698801266: 3.0mm x 47mm Jones Bolt
• 00816988013174: WRx Tray with Irremovable Innermost Tray
• 00816988013129: 4.7mm Proximal Reamer Jones Bolt, Sterile
• 00816988013112: 3.2mm Proximal Reamer Jones Bolt, Sterile
• 00816988013105: 4.0mm Proximal Reamer Jones Bolt, Sterile
• 00816988013099: 5.2mm Proximal Reamer Jones Bolt, Sterile
• 00816988013075: Jones Bolt Instrument Tray Lid
• 00816988013068: Jones Bolt Instrument Tray Base
• 00816988013051: Jones Bolt Reusable Actuation/End Cap Driver Handl
• 00816988013037: 4.7mm Distal Reamer Jones Bolt, Non-Sterile
• 00816988013020: 3.2mm Distal Reamer Jones Bolt, Non-Sterile
• 00816988013013: 4.0mm Distal Reamer Jones Bolt, Non-Sterile
• 00816988013006: 5.2mm Proximal Reamer Jones Bolt, Non-Sterile
• 00816988012993: Tissue Obturator
• 00816988012795: 3.5mmx18mm Quick Thread Screw Sterile
• 00816988012788: 3.5mmx16mm Quick Thread Screw Sterile
• 00816988012771: 3.5mmx14mm Quick Thread Screw Sterile
• 00816988012757: 9.5mm Long End Cap Jones Bolt
• 00816988012733: 7.6mm Long End Cap Jones Bolt
• 00816988012726: 9.5mm End Cap Jones Bolt
• 00816988012719: 7.6mm End Cap Jones Bolt
• 00816988012702: 4.5mm x 47mm Jones Bolt
• 00816988012696: 4.5mm x 40mm Jones Bolt
• 00816988012689: 3.8mm x 40mm Jones Bolt
• 00816988012672: 3.8mm x 47mm Jones Bolt
• 00816988012658: 3.0mm x 40mm Jones Bolt
• 00816988012573: 3.5mmx70mm Quick Thread Screw Sterile
• 00816988012566: 3.5mmx65mm Quick Thread Screw Sterile
• 00816988012559: 3.5mmx60mm Quick Thread Screw Sterile
• 00816988012542: 3.5mmx55mm Quick Thread Screw Sterile
• 00816988012535: 3.5mmx50mm Quick Thread Screw Sterile
• 00816988012528: 3.5mmx45mm Quick Thread Screw Sterile
• 00816988012511: 3.5mmx40mm Quick Thread Screw Sterile
• 00816988012504: Fibulock Instrument Case Screw Caddy and Lid Gen2
• 00816988012498: Fibulock Instrument Case Insert Tray Gen2
• 00816988012481: Fibulock Instrument Case Lid Gen2
• 00816988012474: Fibulock Instrument Case Base Gen2
• 00816988012467: Fibulock Instrument Gase Gen2
• 00816988012450: 3.5mm Cannulated Reamer, Non-Sterile
• 00816988012443: 3.5mm Solid Drill, Sterile
• 00816988012436: Fibulock Disposable Removal Kit
• 00816988012429: Spade-Tip Guide Wire
• 00816988012412: 1.6mm x 9" K-Wire
• 00816988012405: 2.7mm x 12mm Self-Tapping,"PRE-STERILE" Bone Screw
• 00816988012399: 3.5mm Drill Bit Non-cannulated, Sterile
• 00816988012382: 2.7mm x 12mm MINI-CRX Self-Tapping, Bone Screw
• 00816988012375: .062" x 12" K-Wire, Trocar TiN
• 00816988012368: Fib First Gen Bottom Insert Tray
• 00816988010210: Cannulated AO Handle