698335798

GUDID 10705034395173

MODIFIED INSTRUMENT DRILL GUIDE

DEPUY SPINE, LLC

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 10705034395173
• NIH Device Record Key: 6fa5bba0-c130-4fae-b5d1-e17f53afc5f3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 698335798
• Catalog Number: 698335798
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034395173 [Primary]

FDA Product Code

• FZX: Guide, 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: 2023-11-27
• Device Publish Date: 2023-11-17

Devices Manufactured by DEPUY SPINE, LLC

• 10705034003252 - ISOLA: 2024-04-05 ISOLA SPINE SYSTEM SPINAL WIRE WITH BUTTON 177.8mm
• 10705034003269 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM DOUBLE WIRE 304.8mm
• 10705034003276 - ISOLA: 2024-04-03 ISOLA SPINE SYSTEM BEADED WIRE 304.8mm
• 10705034202952 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM WIRE CUTTER
• 10705034302300 - EXPEDIUM: 2024-04-03 EXPEDIUM SPINE SYSTEM SMALL WIRE CUTTER
• 10705034314716 - NA: 2024-04-03 MODIFIED INSTRUMENT ILIAC CUTTER ASSEMBLY 7.25mm
• 10705034484044 - NA: 2024-04-03 MODIFIED INSTRUMENT TREPHINE
• 10705034492353 - NA: 2024-04-03 MODIFIED INSTRUMENT BONE HARVESTER